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General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Under general supervision with detailed instructions on new activities and intermittent review of work, this position is responsible for operating and performing fabrication of machine parts by using light-duty bench or floor-type machine tools such as small lathes power mills, extruding machines, drill or punch presses, power brakes or shears. This is a 2nd shift position working form 3pm to 12:30 am. DUTIES AND RESPONSIBILITIES: Operates drill presses, lathes, mills, saws and shears. Cleans machines and work area. Deburrs parts. Performs kitting of production tools, fixtures, cutters and pre-cut raw material. After complete instruction; operates machines, and inspects parts utilizing blue print dimensions and prescribed gauges. Monitors and verifies quality in accordance with statistical process or other control procedures. Prepares and saw cuts raw materials. May layout, fabricate and assemble components. Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Additional Functions Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a high school diploma, technical/trade school training or equivalent and two or more years related experience. Must be customer focused and possess the ability to perform semi-routine set-up and fabrication of machined parts. Good knowledge of machining equipment including ability to use judgment and safe practices. Ability to read and understand engineering blue prints and diagrams. Skills to maintain the flow of work within the unit. Good interpersonal skills and written communication skills to interface with employees and supervisor; and basic computer skills. Must be able to work both independently and in a team environment. Flexibility to work extended hours as required. Job Category Manufacturing Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 44,590 Pay Range High 66,295 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No Search Jobs at | General Atomics and Affiliated Companies
Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence. Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 10 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $115,000 - $135,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview Reporting to the Director of Accounting, the Senior Accountant is responsible for the monthly close, balance sheet integrity, standard cost maintenance, and gross margin and variance analysis in a manufacturing environment. This is a highly visible role that partners closely with operations, supply chain, and finance leadership to ensure accurate inventory valuation and reliable financial reporting. Success in this role requires deep, expert-level NetSuite proficiency in a manufacturing setting, strong technical accounting judgment, and the ability to work independently with minimal supervision. Excellent communication and cross-functional relationship-building skills are essential. This is an on-site position, Monday through Friday, with flexible start times and a consistent daily schedule. Overtime may be required around close, audit, and budget cycles. This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule. Duties and Responsibilities Own the monthly, quarterly, and year-end close, including preparation and posting of journal entries, accruals, and supporting schedules to produce timely and accurate financial results. Prepare and maintain balance sheet reconciliations, investigating and resolving discrepancies to ensure account integrity. Maintain and update standard costs in NetSuite, including cost rollups from bills of material (BOM), and coordinate periodic updates with operations and supply chain. Analyze gross margin and manufacturing variances (purchase price, material, labor, and overhead), identify root causes, surface trends, and communicate actionable findings to leadership. Ensure accurate inventory valuation and monitor COGS and inventory balances within the general ledger. Support the budgeting, cash flow, and monthly financial reporting processes, including budget-to-actual analysis and management reporting. Support the annual external audit by preparing schedules, reconciliations, and requested documentation, and assist with tax-related matters and filings as needed. Help establish, document, and enforce accounting policies, procedures, and internal controls, and identify opportunities for process and system improvement in NetSuite. Perform ad hoc financial analysis and special projects as requested. Qualifications and Requirements Bachelor's degree in Accounting or Finance. 5+ years of progressive accounting experience, including month-end close ownership and balance sheet reconciliations. 3+ years of accounting experience in a manufacturing and inventory environment. Expert-level NetSuite proficiency in a manufacturing environment (mandatory), including standard costing, BOM/cost rollups, work orders, and inventory/COGS accounting. Demonstrated experience updating standard costs and analyzing gross margin and manufacturing variances. Advanced Microsoft Excel skills. Strong technical accounting knowledge and working understanding of US GAAP. Excellent analytical, critical-thinking, and problem-solving skills, with strong attention to detail. Excellent written and verbal communication skills and the ability to work independently and cross-functionally. Preferred Qualifications CPA or CMA, or active progress toward certification. Experience supporting a carve-out, standalone entity build-out, or high-growth / private-equity-backed environment. Exposure to standard cost roll-forwards tied to annual budget cycles and variance-driven pricing or sourcing decisions. Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
Overview: We are currently seeking a Dog Food Production and Sanitation Worker to join our team. As a Sanitation Worker, you will play a crucial role in maintaining cleanliness and sanitation standards within our facility. This is a physically demanding position that requires attention to detail and the ability to work in a fast-paced environment. Hours are Monday-Thursday from 2:00pm to 10:30pm and Friday 12pm-8:30pm with two paid 10 min. rest breaks, and an unpaid lunch 30 minute lunch. You will also be assisting in producing human-grade dog food. Non-Negotiables: * Be here on time. * Be reliable every day. * Be safe and follow SOPs — no shortcuts. *Primary Responsibilities:* * Set up for pet food production runs * Assist in all aspects of production * Pack and ship finished product onto pallets and load into frozen storage areas * Assist with shipping and receiving of ingredients, equipment, and pet food product * Follow food safety and quality control protocols * Utilize and operate machinery, equipment, and cleaning tools * Adhere to safety guidelines and use personal protective equipment (PPE) when necessary * Clean and sanitize production areas, including equipment, floors, walls, and surfaces * Follow established cleaning procedures and protocols * Maintain inventory of supplies and notify supervisor when reordering is necessary * Perform routine inspections to identify any maintenance or repair needs * Dispose of waste and recyclable materials properly * Collaborate with team members to ensure efficient workflow and timely completion of tasks *Preferred skills:* * Experience in commercial or industrial cleaning * Kitchen or food manufacturing experience * Knowledge of sanitation practices and procedures * Ability to perform heavy lifting and physical tasks for extended periods of time * Familiarity with warehouse or food production environments * Strong attention to detail and ability to follow instructions accurately * Excellent time management skills to prioritize tasks effectively *Physical requirements:* * Ability to Lift: Frequently lift up to 40 pounds or more; occasionally lift up to 80 pounds, including bags of ingredients and finished products. * Stamina: Stand for extended periods (8-12 hours) and perform repetitive tasks. * Mobility: Navigate through production areas, including bending, squatting, and walking on varied surfaces. * Manual Dexterity: Operate machinery and hand tools with precision; ability to perform fine motor tasks. * Visual Acuity: Ability to see details and distinguish colors for quality control and labeling. * Hearing Ability: Hear machinery sounds and alarms in a loud environment for safety monitoring. * Balance and Coordination: Maintain stability while performing tasks in a fast-paced environment. * Adaptability: Tolerance for varying temperatures, humidity, and exposure to dust and allergens. * Strength and Endurance: Ability to engage in physically demanding activities, including pushing and pulling equipment. * Hand-Eye Coordination: Effectively manage tasks requiring coordination between vision and hand movements. * Tolerance for Noise: Ability to work in an environment with loud machinery, wearing appropriate hearing protection as needed. * Machinery Operation: Work with various types of machinery and equipment, which may be sharp, heavy, and require specific training for safe use. *Additional requirements:* * Must be able to reliably commute to Vista, California (92081) * Hold an active food handler’s certification prior to employment, or will be required to become certified upon employment We offer competitive pay rates and opportunities for career growth within our organization. If you are a dedicated individual with a strong work ethic and a commitment to maintaining cleanliness and sanitation standards, we encourage you to apply for the position of Sanitation Worker. Bonus - Friendly environment - We have two friendly office dogs - Free or discounted dog food for you and your family Job Type: Full-time Pay: $19.00 - $21.00 per hour Benefits: * Paid time off Application Question(s): * This job starts at 2:00PM Can you reliably be here every day on time? * If you knew you were going to be late, what would you do? * This job requires standing for long shifts doing repetitive tasks. Are you okay with that? * We have a zero-tolerance policy for drugs or alcohol at work. Can you follow that? * Why are you interested in this position? Location: * Vista, CA 92081 (Required) Shift availability: * Night Shift (Required) Ability to Commute: * Vista, CA 92081 (Required) Work Location: In person
*Summary* We're looking for an experienced Supply Chain Manager to identify, develop, and implement integrated supply chain solutions for a manufacturing operation involving foundry, machining, and turbine/compressor components. This role builds strategic partnerships across internal teams and external suppliers to drive cost-effective, high-performing supply chains. *What You'll Do* * Identify, define, and implement integrated supply chain solutions and performance improvements * Build internal and external alliances to explore new opportunities * Establish and govern effective partnerships and best practices with business partners and internal functions * Assess risk and ensure soundness of business proposals * Research and recommend industry benchmarks, metrics, and best practices * Analyze data to identify and prioritize opportunities for cost-effective supply chains, inventory optimization, and stronger business partnerships *Required Qualifications* * Bachelor's Degree or higher * General understanding of ferrous metallurgy and foundry practices * Good understanding of traditional machining and NDE (non-destructive examination) processes * Familiarity with ASTM, ASME, NACE, and API specifications * Experience in Supply Chain and Customer Relationship Management * Experience in production management * Good understanding of Lean/Six Sigma and Theory of Constraints * Established network of industry leaders * General knowledge of turbine and compressor design and requirements Pay: $150,000.00 - $210,000.00 per year Benefits: * Dental insurance * Health insurance * Life insurance * Vision insurance Application Question(s): * Do you have a bachelor's degree or higher? * Do you have experience in Supply Chain Management? * Do you have experience in production management? * Do you have a general understanding of ferrous metallurgy and/or foundry practices? * Are you familiar with ASTM, ASME, NACE, or API specifications? * Do you have experience with Lean/Six Sigma or Theory of Constraints? * Do you have general knowledge of turbine and compressor design and requirements? * Do you have an established network of industry contacts/leaders? * Are you legally authorized to work in the United States? Work Location: In person
Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Senior Validation Engineer (CQV) — Equipment & Cleaning Validation Join a leading biopharmaceutical manufacturer in the San Diego area as a Senior Validation Engineer supporting equipment and cleaning validation at a large-scale biologics manufacturing site. This is a hands-on contract role where you'll drive validation for upcoming tech transfers and equipment qualifications in a cGMP environment — a strong fit if you want high-impact field work at an established, stable operation without relocating out of Southern California. About the Opportunity You'll embed with an established validation team to support day-to-day validation activities and a pipeline of upcoming projects. Your focus will be equipment and cleaning validation — authoring and executing protocols, troubleshooting test results, and keeping documentation audit-ready as new tech transfers and equipment modifications come online. The work is central to keeping the site inspection-ready and its products flowing, so your judgment and technical rigor will be visible and valued. What You'll Do Author and execute validation protocols for equipment and systems, including cleaning validation Lead troubleshooting and data analysis for validation test results Support tech transfers, equipment modifications, and requalification activities Maintain precise, audit-ready validation records and documentation Ensure all deliverables align with applicable industry and regulatory standards Partner cross-functionally with engineering, manufacturing, and quality teams to keep projects on schedule What You Bring Required: 10+ years of validation experience in a cGMP biopharmaceutical or life sciences environment Demonstrated depth in equipment validation and cleaning validation Strong protocol authoring and technical writing skills Proven technical problem-solving and data analysis capability Preferred: Experience supporting tech transfers or equipment qualification/requalification programs Familiarity with automated process systems and control platforms (e.g., DeltaV) Track record collaborating across engineering, operations, and quality functions Details Work arrangement: 100% onsite, fully site-based Employment type: Contract, 12 months with possibility of extension Compensation: $65–$75/hour, depending on experience Location: San Diego area Ready to Apply? If you're a validation professional who takes ownership of your deliverables and thrives on hands-on field execution, we'd like to hear from you. Even if you don't check every box, we encourage you to apply — strong equipment and cleaning validation experience is what matters most. Why Join Valspec? At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including: Premium medical coverage 401(k) with company match Tuition reimbursement Unique performance incentives And more — all designed to support your growth, well-being, and future. Join a team where your contributions matter, your development is prioritized, and your success is shared. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Come be part of Dexcom San Diego Pilot Operations team! As a Production Chemist 3, you will be responsible for analytical testing of materials and parts that support our future development and current bio-sensor designs. You will be collaborating with research and development scientists, sustaining quality and process engineers and process development engineers to develop and improve test methods and to maintain cGMP compliance. You will provide guidance and training to other test associates, and incoming new hires, as needed. You will also be involved in IQ/OQ/PQ process for new instruments added to the analytical lab. A positive attitude is important while working in a fast-paced environment. Where you come in: You will provide technical leadership for the analytical chemical and material analysis for Pilot Test and Chemistry labs You will perform chemical analysis of samples following ASTM standard methods and internally developed methods, including High-Performance Liquid Chromatography, Gel Permeation Chromatography, Glucose concentration analysis, Differential Scanning Calorimetry, Scanning Electron Microscopy, Karl Fischer titration, Dynamic Light Scattering, and UV-Vis spectroscopy. You will perform data analysis on results and statistical analysis on data and secondary data review when required. You will ensure samples are processed in a timely and efficient manner and provide regular reports on the status of sample analysis. You may assist in method development, method validation or method improvement as needed. You maintain a safe working environment and adhere to safety protocols and 6S practices. You maintain accurate records for all laboratory activities, including test results, deviations, and reports. You will lead/support investigations of deviations or results that are out-of-specification. You will maintain analytical instruments and perform minor routine maintenance on instruments as required. What makes you successful: You have a background in Analytical Chemistry and several years of experience in analytical QC in the pharmaceutical, medical device or polymer industry. You are proficient in complex analytical techniques and instruments (e.g. GPC and HPLC), as well as defining and executing test method validation. You have experience in statistical analysis of laboratory results. You have experience in reviewing and taking corrective actions when needed in response to technical or operational issues in relation to analytics and instrumentation. You have excellent problem-solving skills and attention to detail. Optional: You bring a strong knowledge of regulatory requirements for medical devices or pharmaceuticals (Part 11 compliance). Optional: You have strong knowledge in Lean manufacturing and testing principles What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 0-5% Experience and Education Requirements: Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $100,700.00 - $167,900.00
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Lead, Manufacturing Operations is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities. The Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream. Example Plan Shifts/Training Schedule: - First 2 weeks: 8 hour shifts, M-F - Next 1-2 months: 10 hour shifts, Mon-Thurs - After 90 days: 12 hour shifts, Sun-Tues & Alternating Wednesdays Schedule is subject to change based on needs. Responsibilities Manufacturing Operations Individual Skills Provide hands-on training for upstream staff to ensure compliance with training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. Perform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills. Monitor processes and results and troubleshoot issues as they arise to ensure process success. Lead and guide associates through process and workflow improvement initiatives. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE. Perform downstream production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. Enforce cleanroom standards for cleanliness and order Direct floor operations for multiple projects simultaneously. Make adjustments as necessary to adhere to production schedules. Cross-train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. Represent departmental activities as needed, including project teams and task forces. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Manufacturing Operations Leadership Lead day-to-day execution of upstream and downstream GMP manufacturing activities. Coordinate manufacturing floor activities and provide real-time direction to manufacturing associates during campaign execution. Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling. Ensure activities are performed according to approved batch records, SOPs, and production schedules. Provide hands-on training and qualification support for manufacturing personnel. Review GMP documentation for completeness, accuracy, and compliance. Support deviations, CAPAs, change controls, and quality events. Troubleshoot process, equipment, and operational issues. Champion EHS compliance and safe work practices. Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management. Team Leadership & Development Train Manufacturing Associates. Provide feedback and review of staff during performance evaluations. Facilitate onboarding and qualification of new employees. Promote a culture of safety, teamwork, accountability, and continuous improvement. Lead daily shift meetings, production reviews, and operational communications. GMP Compliance & Quality Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements. Review and verify batch documentation for accuracy and completeness. Support investigations, deviations, CAPAs, change controls, and quality events. Participate in internal audits, client audits, and regulatory inspections. Ensure proper documentation practices and data integrity standards are maintained. Process Execution & Technical Support Provide technical oversight for upstream and downstream operations. Support process transfers from development to GMP manufacturing. Assist in process validation, engineering runs, and GMP campaign readiness activities. Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency. Troubleshoot manufacturing and equipment-related issues. Safety & Operational Excellence Champion Environmental Health and Safety (EHS) compliance. Ensure safe handling of biological materials, chemicals, and manufacturing equipment. Lead risk assessments and support implementation of corrective actions. Drive Lean Manufacturing and continuous improvement initiatives. Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence. Cross-Functional Collaboration Partner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams. Support customer visits and client-facing manufacturing discussions as required. Ensure manufacturing readiness through effective planning and material coordination. Qualifications BA/BS degree that included laboratory work in a chemistry, biology, or related field. At least 3 – 4 years of purification experience in a GMP pharmaceutical/biotech environment role. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems. Skilled with using single-use technologies Strong technical and mechanical aptitude in bioprocessing. Knowledge of purification using column chromatography Experience leading, training, and coaching peers. Computer proficiency A proven ability to confidently compute basic arithmetic operations. Travel between Abzena sites (local San Diego CA facilities ) as needed. Physical Requirements Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects at least 30 pounds in weight. Stand/walk during entire length of shift. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus. FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Lead, Manufacturing Operations is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities. The Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream. Example Plan Shifts/Training Schedule: - First 2 weeks: 8 hour shifts, M-F - Next 1-2 months: 10 hour shifts, Mon-Thurs - After 90 days: 12 hour shifts, Thurs-Sat & Alternating Wednesdays Schedule is subject to change based on needs. Responsibilities Manufacturing Operations Individual Skills Provide hands-on training for upstream staff to ensure compliance with training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. Perform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills. Monitor processes and results and troubleshoot issues as they arise to ensure process success. Lead and guide associates through process and workflow improvement initiatives. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE. Perform downstream production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. Enforce cleanroom standards for cleanliness and order Direct floor operations for multiple projects simultaneously. Make adjustments as necessary to adhere to production schedules. Cross-train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. Represent departmental activities as needed, including project teams and task forces. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Manufacturing Operations Leadership Lead day-to-day execution of upstream and downstream GMP manufacturing activities. Coordinate manufacturing floor activities and provide real-time direction to manufacturing associates during campaign execution. Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling. Ensure activities are performed according to approved batch records, SOPs, and production schedules. Provide hands-on training and qualification support for manufacturing personnel. Review GMP documentation for completeness, accuracy, and compliance. Support deviations, CAPAs, change controls, and quality events. Troubleshoot process, equipment, and operational issues. Champion EHS compliance and safe work practices. Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management. Team Leadership & Development Train Manufacturing Associates. Provide feedback and review of staff during performance evaluations. Facilitate onboarding and qualification of new employees. Promote a culture of safety, teamwork, accountability, and continuous improvement. Lead daily shift meetings, production reviews, and operational communications. GMP Compliance & Quality Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements. Review and verify batch documentation for accuracy and completeness. Support investigations, deviations, CAPAs, change controls, and quality events. Participate in internal audits, client audits, and regulatory inspections. Ensure proper documentation practices and data integrity standards are maintained. Process Execution & Technical Support Provide technical oversight for upstream and downstream operations. Support process transfers from development to GMP manufacturing. Assist in process validation, engineering runs, and GMP campaign readiness activities. Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency. Troubleshoot manufacturing and equipment-related issues. Safety & Operational Excellence Champion Environmental Health and Safety (EHS) compliance. Ensure safe handling of biological materials, chemicals, and manufacturing equipment. Lead risk assessments and support implementation of corrective actions. Drive Lean Manufacturing and continuous improvement initiatives. Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence. Cross-Functional Collaboration Partner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams. Support customer visits and client-facing manufacturing discussions as required. Ensure manufacturing readiness through effective planning and material coordination. Qualifications BA/BS degree that included laboratory work in a chemistry, biology, or related field. At least 3 – 4 years of purification experience in a GMP pharmaceutical/biotech environment role. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems. Skilled with using single-use technologies Strong technical and mechanical aptitude in bioprocessing. Knowledge of purification using column chromatography Experience leading, training, and coaching peers. Computer proficiency A proven ability to confidently compute basic arithmetic operations. Travel between Abzena sites (local San Diego CA facilities ) as needed. Physical Requirements Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects at least 30 pounds in weight. Stand/walk during entire length of shift. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus. FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Description: The Plant Assistant works under the direction of the Area Manager, Plant Manager, or Assistant Plant Manager to support the safe and efficient production of concrete. This role includes general labor, equipment operation, and maintenance duties to ensure smooth plant operations. Essential Functions of the Position: • Perform physical labor tasks such as digging, lifting, carrying, and moving materials. • Operate loaders, yard tractors, water trucks, sweepers, and any other equipment necessary. • Utilize preventative maintenance on all yard and plant equipment to ensure they function properly. • Perform pre-/post-trips on equipment to ensure that the equipment can be operated safely. • Load and unload materials and equipment from trucks and other vehicles. • Maintain a clean and organized work area, including cleaning up debris and waste. • Adhere to all safety regulations and protocols, including wearing appropriate personal protective equipment (PPE). • Communicate effectively with supervisors and coworkers. • Perform other duties as assigned by supervisors or plant managers. • Able to work full time and overtime if needed. • Able to travel and work at other plants when needed. Skills and Knowledge: • Basic mechanical knowledge to assist in diagnosing, reporting, and repairing minor equipment or production issues. • Ability to operate heavy equipment such as loaders, yard tractors, man lifts, etc. • General understanding of equipment safety and maintenance procedures. • Strong communication and teamwork skills. Requirements: • Must have a valid Class C driver’s license. • Must have reliable transportation. • Driver record cannot contain any reckless driving offences, DUIs, leaving the scene of an accident, etc. • Driver record cannot contain more than 1.5 active points in the last 36 months. • Ability to follow written and verbal directions and to complete assigned tasks on schedule. • Ability to read, write, and communicate effectively in English. • Ability to work with supervision, receiving instructions/feedback, coaching/counseling and/or action/discipline. Physical Demands: The physical demands described here represent those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions: • Ability to work outside in various weather conditions while sitting or standing for extensive periods of time. • Ability to kneel, reach, or lift to 50 pounds or more. • Ability to climb ladders to access higher elevations on batch plants. Benefits: • Medical Insurance, Dental HMO/PPO, Vision, Basic and Voluntary Life, and Voluntary Accident. • Employee Assistance Program (EAP) • 401 (k) Retirement Plan- Company match • Paid Sick time. • Paid Holidays • Paid Vacations • Direct Deposit • Paid weekly. • Referral Bonus This job description does not imply that the listed duties are the only responsibilities of an employee in this position. Employees may be asked to perform additional tasks as needed to ensure adequate workload coverage. Furthermore, employees must follow any job-related instructions and complete any other duties assigned by their supervisor. This job description does not constitute an employment agreement between the employer and the employee and may be changed by the employer as organizational needs and job requirements of the job change.
Introduction to the Job ASML US, including its affiliates and subsidiaries, bring together the most creative minds in science and technology to develop lithography machines that are key to producing faster, cheaper, more energy-efficient microchips. We design, develop, integrate, market and service these advanced machines, which enable our customers - the world’s leading chipmakers - to reduce the size and increase the functionality of their microchips, which in turn leads to smaller, more powerful consumer electronics. Our headquarters are in Veldhoven, Netherlands, and we have 18 office locations around the United States including main offices in Chandler, Arizona, San Jose and San Diego, California, Wilton, Connecticut, and Hillsboro, Oregon. As a Manufacturing Technician you will build and test sub-systems of the ASML EUV Source, responsible for building and testing laser sub-system modules and validating manufacturing processes. You must be work authorized in the United States without the need for employer sponsorship. Role and Responsibilities Uses standardized tools and electronic equipment (i.e., torque wrenches, electric and pneumatic screwdrivers and ball drivers, lifting equipment, computers, oscilloscopes) to assemble/install/remove or perform testing and troubleshooting. Solders small wires under microscope Trains others on areas of test processes and troubleshooting when required. Performs a variety of moderately complex technical service/support duties requiring specialized knowledge (i.e., sub-assembly, assembly, build, test, R&D, QA). Interfaces with engineers to support special tests and experiments with detailed instructions. Documents and monitors safety or security violations critical to product quality or operations. Uses specialized test equipment such as leak testing, Hi - Pot and alignment instruments. Pressurizes Gas, and Water systems with Helium and troubleshoot failures. Reads and understands business documents such as Bill of Materials, routing sheets, inventory records and work instructions. Applies labels to panels, modules, and doors to cleanliness and workmanship standards. Uses cleaning cloths with Acetone, Methanol, and Isopropyl alcohol to wipe surfaces prior to shipping product. Maintains a clean work area, and is responsible for sustaining 5S standard work areas. Installs electrical connectors to modules. Performs other duties as assigned. Job description subject to change at any time Education & Experience Knowledge base generally requires AS or related degree. Requires a High School Diploma or equivalent. Preferred minimum of two (2) years of experience; may have fewer years of experience with a Bachelor's degree. Associate's Degree in technical or scientific field is highly desired. Experience in using all electronic/pneumatic tools. Skills & Competencies Excellent written and verbal communication skills. Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats. Ability to use MS Word, Excel, PowerPoint, and electronic e-mail systems. Ability to read and interpret schematics/drawings. Ability to apply advanced knowledge of Company policies and technical skills in support of multiple products, services and components. Strong Mechanical and/or electronic background preferred. Ability to troubleshoot, identify and correct problems in complex software-driven electronic systems, (not circuit-board troubleshooting). Familiarity with cleanroom protocol is preferred. Full to advanced proficiency with a wide variety of tools and equipment (e.g., oscilloscopes, voltage and current probes, multi-meters, chart recorders, and Helium Sniffers). Work Schedule: 0630-1900 Thursday-Saturday/ Wednesday-Saturday (alternating weekly) Other Information PHYSICAL DEMANDS AND WORK ENVIRONMENT The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee routinely is required to sit; walk; talk; hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch. The employee is occasionally required to move around the campus. The employee may occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Can work under deadlines. The environment generally is moderate in temperature and noise level. Must wear all approved cleanroom attire; facemask, hood, coveralls, safety shoes, eyewear & gloves. Must be able to read and interpret data, information, and documents. Can observe and respond to people and situations and interact with others encountered in the course of work. Can learn and apply new information or skills. The current base annual hourly range for this role is currently: $22.90-34.34 Pay scales are determined by role, level, location and alignment with market data. Individual pay is determined through interviews and an assessment of several factors that that are unique to each candidate, including but not limited to job-related skills, relevant education and experience, certifications, abilities of the candidate and pay relative to other team members. The Company offers employees and their families, medical, dental, vision, and basic life insurance. Employees are able to participate in the Company’s 401k plan. Employees will also receive eight (8) hours of vacation leave every month and (13) paid holidays throughout the calendar year. For more information, please contact the Recruiter or click on this link Compensation & Benefits in the US . All new ASML jobs have a minimum application deadline of 10 days. This position requires access to controlled technology, as defined in the United States Export Administration Regulations (15 C.F.R. § 730, et seq.). Qualified candidates must be legally authorized to access such controlled technology prior to beginning work. Business demands may require ASML to proceed with candidates who are immediately eligible to access controlled technology. Inclusion and diversity ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that inclusion and diversity is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions . Request an Accommodation ASML provides reasonable accommodations to applicants for ASML employment and ASML employees with disabilities. An accommodation is a change in work rules, facilities, or conditions which enable an individual with a disability to apply for a job, perform the essential functions of a job, and/or enjoy equal access to the benefits and privileges of employment. If you are in need of an accommodation to complete an application, participate in an interview, or otherwise participate in the employee pre-selection process, please send an email to USHR_Accommodation@asml.com to initiate the company’s reasonable accommodation process. Please note: This email address is solely intended to provide a method for applicants to initiate ASML’s process to request accommodation(s). Any recruitment questions should be directed to the designated Talent Acquisition member for the position.
About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Quality Engineer (Operations) Quality Location: San Diego, CA (On-site) Employment Type: Full-Time About the Role As Senior Quality Engineer (Operations), you will serve as the Quality lead supporting Synchron’s manufacturing operations, contract manufacturers, and supplier network to ensure products are manufactured safely, consistently, and in compliance with applicable regulatory requirements. You will partner closely with Manufacturing Engineering, Supply Chain, Operations, and R&D to establish robust manufacturing processes, support design transfer activities, and drive continuous improvement across production operations. You will also assist in the development and implementation of Synchron’s QMS. This is a hands-on role requiring regular engagement on the manufacturing floor, with suppliers, and across cross-functional teams. Key Responsibilities Manufacturing Quality Serve as the Quality representative supporting manufacturing operations and production readiness. Develop and maintain manufacturing quality plans, inspection methods, acceptance criteria, and process controls. Monitor production quality metrics including yield, defects, scrap, and process capability; identify trends and drive continuous improvement. Support manufacturing investigations related to nonconforming product, deviations, and production issues. Lead root cause investigations using structured problem-solving methodologies and ensure timely implementation of effective CAPAs. Support Manufacturing Engineering during implementation of new equipment, tooling, automation, and process improvements. Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits. Process Validation & Manufacturing Readiness Lead or support process validation activities (IQ/OQ/PQ) for manufacturing processes, equipment, software, and inspection systems. Develop validation protocols, reports, sampling plans, and acceptance criteria. Support manufacturing process characterization and statistical analysis. Maintain validated state through periodic review and change assessment. Participate in pilot builds and production readiness activities supporting commercialization. Supplier & Contract Manufacturer Quality Manage quality oversight of suppliers and contract manufacturers. Conduct supplier qualification, audits, performance monitoring, and quality system assessments. Review supplier validation documentation, inspection methods, and process controls. Maintain supplier quality agreements and supplier performance scorecards. Partner with Supply Chain to resolve supplier quality issues and implement corrective actions. Design Transfer & Change Management Partner with R&D and Manufacturing Engineering to ensure successful transfer of new products into production. Develop Process FMEAs, Control Plans, inspection strategies, and manufacturing quality documentation. Evaluate manufacturing impact of engineering changes through Change Control processes. Support Design Reviews with a focus on manufacturability, inspection, process capability, and production scalability. Quality Systems & Compliance Author and maintain manufacturing quality documentation including SOPs, Work Instructions, Inspection Procedures, DHRs, Device Master Records (DMRs), and validation documentation. Support internal audits, supplier audits, FDA inspections, and Notified Body audits. Ensure manufacturing activities remain compliant with FDA Quality System Regulation, ISO 13485, and applicable international standards. Support implementation and continuous improvement of Synchron’s Quality Management System. Continuous Improvement Drive Lean Manufacturing and Operational Excellence initiatives. Utilize SPC, capability studies, MSA, Gage R&R, and statistical tools to improve manufacturing performance. Develop quality metrics and dashboards to support management review. Champion risk-based decision making throughout manufacturing operations. Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field 7+ years of quality engineering experience in an FDA-regulated medical device environment, with hands-on experience supporting development and manufacturing of mechanical and/or electrical devices, including process validation and control plan development.SES, CERTIFICATIONS Preferred Qualifications ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred. Ability to read engineering drawings, GD&T, and electrical schematics; hands-on experience with electromechanical assembly and inspection Lean manufacturing tools (5S, Kaizen, Statistical Process Control, poka-yoke) and applied statistics (sampling plans, MSA/Gage R&R) Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable product standards (IEC 60601-1, ISO 14708, ISO 10993, IEC 62366) Supplier quality management experience: auditing, corrective action, and quality agreements Strong communicator – able to author clear technical documents and collaborate across R&D, manufacturing, regulatory, and operations Ability to work effectively within fast-paced, cross-functional teams with shifting priorities 8+ years of medical device quality engineering experience, with 3+ years in a manufacturing environment Class III implantable device experience – neuromodulation, vascular, or cardiac rhythm management preferred Experience supporting FDA or Notified Body inspections and/or regulatory submissions Compensation The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position at this time. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) Life insurance, short-term disability, long-term disability 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.
About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Quality Engineer (New Product Development) Quality Location: San Diego, CA (On-site) Employment Type: Full-Time About the Role As Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron’s product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. You will lead Design Quality activities, ensure compliance with FDA, ISO 13485, ISO 14971, and applicable international regulations, and facilitate successful transfer of new products into manufacturing. You will also provide operational quality support during pilot builds and early production while contributing to the development and continuous improvement of Synchron’s Quality Management System. Key Responsibilities Design Quality & New Product Development Serve as the Quality representative on cross-functional product development teams from concept through commercialization. Ensure compliance with Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulations. Lead Design Quality deliverables including: Design Reviews Design Verification & Validation (V&V) Design History File (DHF) development Traceability Engineering Change Assessments Facilitate product risk management activities in accordance with ISO 14971, including hazard analyses, risk assessments, FMEAs, and verification of risk controls. Review and approve product requirements, specifications, protocols, reports, drawings, and engineering documentation to ensure quality and regulatory compliance. Collaborate with engineering teams to establish critical quality attributes, acceptance criteria, and design inputs/outputs. Drive Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Quality (DFQ) principles throughout development. Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits. Design Transfer & Manufacturing Readiness Partner with R&D and Manufacturing Engineering to execute successful design transfer into production. Develop manufacturing quality strategies including Process FMEAs, Control Plans, inspection strategies, and manufacturing quality gates. Support process validation activities (IQ/OQ/PQ), equipment qualification, and pilot manufacturing builds. Evaluate manufacturing readiness and identify quality risks prior to product launch. Support engineering changes through impact assessments and change control activities. Operations & Supplier Quality Collaborate with Operations and Supplier Quality to qualify suppliers and contract manufacturers supporting new product development. Review supplier validation activities, incoming inspection strategies, and quality documentation. Support investigations involving nonconforming materials, manufacturing deviations, and CAPAs associated with prototype and pilot production. Monitor quality metrics during new product introduction (NPI) and drive continuous improvement initiatives. Quality Systems & Regulatory Support Author and maintain Design Quality documentation including: Design Plans DHFs Risk Management Files SOPs Quality Plans Verification & Validation protocols and reports Support Regulatory Affairs during submissions by ensuring quality documentation is complete and inspection-ready. Participate in internal audits, supplier audits, FDA inspections, and Notified Body audits. Contribute to continuous improvement of Synchron’s Quality Management System. Required Qualifications Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field 7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer. Experience supporting Class III medical devices preferred. CERTIFICATIONS Preferred Qualifications ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred. Demonstrated knowledge of FDA Design Controls and product development processes. Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable product standards. Experience with Design Verification, Validation, Design Reviews, Design History Files, and traceability. Experience performing Design and Process FMEAs and applying risk management principles. Knowledge of process validation (IQ/OQ/PQ), manufacturing process development, and design transfer. Familiarity with supplier quality management and contract manufacturing. Ability to interpret engineering drawings, GD&T, and product specifications. Strong technical writing and documentation skills. Excellent communication and collaboration skills within multidisciplinary development teams. Ability to balance innovation with regulatory compliance in a fast-paced product development environment. Compensation The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) Life insurance, short-term disability, long-term disability 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.