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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 instruction for new work or a special assignment, this position is responsible for performing a wide variety of repetitive or standard electronic and /or mechanical assemblies and subassemblies. Determines and/or follows methods and sequence of operations in performing assembly tasks such as wiring, component installation, hand soldering and cable harnessing on assembly units. May monitor and verify quality in accordance with control procedures. This position is for the second shift. DUTIES & RESPONSIBILITIES: Assembles components, assemblies or sub-assemblies. Makes setups and adjustments holding tolerances to specifications. May perform duties as required in assembly of electronic equipment such as cables, harnesses, chassis, and printed circuit boards, or may perform mechanical assembly of panels, LRU's, batteries, and servo motors. May disassemble, modify, rework, and reassemble assemblies or subassemblies. 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 May assist in training lower level assemblers. Performs housekeeping and cleanup duties upon completion of assigned tasks. 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 Typical requires a high school diploma or equivalent and five or more years experience. Proficient in the use of hand tools and torque wrenches; must have a solid understanding of prevailing torque and its proper application. Must be customer focused and possess: The ability to read and interpret engineering drawing and wire lists. Good understanding of the general aspects of the job with limited technical comprehension. Knowledge of computer operations and applications pertinent to the position. Familiarity with use of soldering and compression connection tools. Good visual perception and ability to distinguish between colors. Strong reading comprehension skills. The ability to work independently or in a team environment is essential. Job Category Manufacturing Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 48,160 Pay Range High 71,598 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No Search Jobs at | General Atomics and Affiliated Companies
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. We have an exciting opportunity for a 2nd Shift Mechanical Inspector- Receiving Inspection to join our Poway, CA team. This position inspects parts, assemblies, tooling, fixtures, and materials to ensure compliance with customer, engineering, and quality requirements in an aerospace/defense manufacturing environment. DUTIES AND RESPONSIBILITIES: Perform complex dimensional and visual inspection of machined, fabricated, and supplier-provided hardware using engineering drawings, specifications, purchase order requirements, and inspection plans. Interpret GD&T and use precision measuring equipment; perform or review CMM inspections and reports as needed. Review supplier documentation, including certificates of conformance, material and special process certifications, test reports, and dimensional records. Review and verify AS9102 First Article Inspection (FAI) packages for completeness, characteristic accountability, revision accuracy, and objective evidence. Support Local Source Inspection at suppliers or alternate locations, representing the company professionally and following approved work instructions. Distinguish true nonconformances from documentation issues and escalate per procedures. Support internal, customer, regulatory, and quality system audits with accurate inspection records. Inspect or verify tooling, fixtures, gauges, and inspection aids when required. Comply with company procedures, safety and quality requirements, and applicable regulations; maintain confidentiality of sensitive information. Work independently or in a team and support overtime, priority inspections, alternate work locations, and supplier visits as needed. Good communication skills to effectively interface with all levels of employees including management. 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 an associate's degree, trade school certificate, military training or equivalent in quality inspections or certification by a professional group such as ASQ or AWS, and one or more years of progressive experience in electrical, mechanical, electromechanical or metrology inspection and calibration. May substitute additional experience in lieu of formal education and training. Progressive experience in aerospace, defense, mechanical, dimensional, or receiving inspection. Strong knowledge of AS9100 requirements related to inspection, acceptance records, traceability, calibration, and nonconforming material control. Proficiency in GD&T interpretation and dimensional inspection methods. Ability to obtain and maintain DoD Security Clearance required. Preferred Experience with AS9102, SAP/QMS, and CMM inspection. SQ, AWS, AS9102, GD&T, DFARS, Mil-STD or equivalent quality/inspection certifications. Experience with ISO 9001, quality assurance program requirements and ASME Y14.5 are desirable. IPC 610 & IPC 620 certification . Experience as an CMM operator and CMM programming, highly preferred. Job Category Quality Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 52,020 Pay Range High 77,325 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? Desired Clearance Level Secret Search Jobs at | General Atomics and Affiliated Companies
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. We have an exciting opportunity for a 2nd Shift Mechanical Inspector- Receiving Inspection to join our Poway, CA team. This position inspects parts, assemblies, tooling, fixtures, and materials to ensure compliance with customer, engineering, and quality requirements in an aerospace/defense manufacturing environment. DUTIES AND RESPONSIBILITIES: Perform complex dimensional and visual inspection of machined, fabricated, and supplier-provided hardware using engineering drawings, specifications, purchase order requirements, and inspection plans. Interpret GD&T and use precision measuring equipment; perform or review CMM inspections and reports as needed. Review supplier documentation, including certificates of conformance, material and special process certifications, test reports, and dimensional records. Review and verify AS9102 First Article Inspection (FAI) packages for completeness, characteristic accountability, revision accuracy, and objective evidence. Support Local Source Inspection at suppliers or alternate locations, representing the company professionally and following approved work instructions. Distinguish true nonconformances from documentation issues and escalate per procedures. Support internal, customer, regulatory, and quality system audits with accurate inspection records. Inspect or verify tooling, fixtures, gauges, and inspection aids when required. Comply with company procedures, safety and quality requirements, and applicable regulations; maintain confidentiality of sensitive information. Work independently or in a team and support overtime, priority inspections, alternate work locations, and supplier visits as needed. Good communication skills to effectively interface with all levels of employees including management. 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 an associate's degree, trade school certificate, military training or equivalent in quality inspections or certification by a professional group such as ASQ or AWS, and one or more years of progressive experience in electrical, mechanical, electromechanical or metrology inspection and calibration. May substitute additional experience in lieu of formal education and training. Progressive experience in aerospace, defense, mechanical, dimensional, or receiving inspection. Strong knowledge of AS9100 requirements related to inspection, acceptance records, traceability, calibration, and nonconforming material control. Proficiency in GD&T interpretation and dimensional inspection methods. Ability to obtain and maintain DoD Security Clearance required. Preferred Experience with AS9102, SAP/QMS, and CMM inspection. SQ, AWS, AS9102, GD&T, DFARS, Mil-STD or equivalent quality/inspection certifications. Experience with ISO 9001, quality assurance program requirements and ASME Y14.5 are desirable. IPC 610 & IPC 620 certification. Experience as an CMM operator and CMM programming, highly preferred. Job Category Quality Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 52,020 Pay Range High 77,325 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? Desired Clearance Level Secret Search Jobs at | General Atomics and Affiliated Companies
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 instruction for new work or a special assignment, this position is responsible for performing a wide variety of repetitive or standard electronic and /or mechanical assemblies and subassemblies. Determines and/or follows methods and sequence of operations in performing assembly tasks such as wiring, component installation, hand soldering and cable harnessing on assembly units. May monitor and verify quality in accordance with control procedures. DUTIES & RESPONSIBILITIES: Assembles components, assemblies or sub-assemblies. Makes setups and adjustments holding tolerances to specifications. May perform duties as required in assembly of electronic equipment such as cables, harnesses, chassis, and printed circuit boards, or may perform mechanical assembly of panels, LRU's, batteries, and servo motors. May disassemble, modify, rework, and reassemble assemblies or subassemblies. 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 May assist in training lower level assemblers. Performs housekeeping and cleanup duties upon completion of assigned tasks. 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 Typical requires a high school diploma or equivalent and three or more years experience. Proficient in the use of hand tools and torque wrenches; must have a solid understanding of prevailing torque and its proper application. Must be customer focused and possess: The ability to read and interpret engineering drawing and wire lists. Good understanding of the general aspects of the job with limited technical comprehension. Knowledge of computer operations and applications pertinent to the position. Familiarity with use of soldering and compression connection tools. Good visual perception and ability to distinguish between colors. The ability to work independently or in a team environment is essential as is the ability to work extended hours as required. Job Category Manufacturing Experience Level Mid-Level (3-7 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
The Quality Engineer Level 3 – Risk Management is an experienced individual contributor within Regulatory and Quality for Diagnostics. This role is responsible for performing and maintaining product and process risk management activities for medical device and/or in-vitro diagnostic products across the full product lifecycle. The position supports new product development, sustaining activities, manufacturing, supplier quality, post-market surveillance, complaints, CAPA, nonconformances, and change management. The role partners with cross-functional teams, including Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market teams, to ensure risk management activities are completed in accordance with applicable quality system requirements, FDA regulations, ISO 13485, ISO 14971, and other relevant medical device and IVD regulatory expectations. Knowledge Product and process risk management principles for medical devices and IVD products. FDA Quality System requirements and applicable regulatory expectations. ISO 13485 and ISO 14971 requirements. QSR, CDRH, IVDR, MDR, MDSAP, and IEC 62304 regulations and standards. Design controls and their relationship to risk management. Hazard analysis, use-related risk assessment, fault tree analysis, DFMEA, PFMEA, safety risk analysis, product risk assessments, and benefit-risk evaluations. Complaint handling, CAPA, nonconformance, change control, validation, and post-market surveillance processes. Root cause analysis and corrective action methods. Technical documentation, including requirements, specifications, verification and validation reports, manufacturing procedures, quality records, and risk files. Audit and inspection readiness expectations for internal audits, external audits, regulatory inspections, and supplier audits. Skills The successful candidate should demonstrate the ability to: Independently perform assigned risk management activities across product development, manufacturing, sustaining, and post-market lifecycle phases. Develop, review, maintain, and evaluate risk management documentation and deliverables. Assess whether product, process, software, supplier, manufacturing, service, or labeling changes introduce new hazards or affect existing risk controls. Identify, verify, and evaluate the effectiveness of risk controls. Interpret technical documentation and identify quality, compliance, or risk implications. Produce clear, objective, technically accurate, and inspection-ready documentation. Apply analytical thinking, problem-solving, root cause analysis, and risk-based decision-making. Support cross-functional teams, design reviews, change review boards, CAPA teams, complaint investigations, and material review activities. Provide subject matter input during audits, inspections, and readiness activities. Manage multiple priorities and meet project timelines in a dynamic regulated environment. Communicate effectively through written, verbal, and interpersonal interactions. Behavior Works independently on defined assignments while recognizing when escalation is needed. Demonstrates strong attention to detail and a commitment to high-quality standards. Collaborates effectively with stakeholders across Quality, Regulatory, R&D, Manufacturing, Supplier Quality, Customer Service, Commercial/Sales, and Post-Market teams. Maintains objectivity and technical accuracy in risk documentation and assessments. Supports a culture of compliance, inspection readiness, and continuous improvement. Escalates complex risk questions, safety concerns, or unresolved risk acceptability issues to management or senior technical leaders. Contributes constructively to cross-functional decision-making and risk-based discussions. Adapts to changing priorities while maintaining focus on quality, compliance, and product safety. Experience A minimum of a Bachelor’s degree in engineering, life sciences, biomedical sciences, quality, or a related technical discipline. 5+ years of related experience in a regulated medical device, IVD, quality engineering, or product development environment. Experience supporting risk management files, hazard analyses, FMEAs, design control documentation, change control, complaints, CAPA, and/or nonconformance processes. Experience working on cross-functional teams in regulated product development or sustaining engineering environments. Experience evaluating post-market information such as complaints, deviations, nonconformances, service data, and other feedback for potential risk impact. Experience supporting internal audits, external audits, regulatory inspections, supplier audits, and inspection readiness activities. Practical experience reviewing and maintaining risk files throughout product development, manufacturing, and post-market surveillance phases. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $98,500 - $154,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-AV1
The position is responsible for validation activities covering analytical methods, cleaning, production processes, equipment qualification, facilities/utilities qualification, and raw materials qualification. The role also includes generating and maintaining process FMEA, performing risk assessments for process-related non-conformances and planned deviations, supporting regulatory submissions, writing master validation plans, protocols, and reports, supporting equipment and facilities change controls, and performing validation impact assessments for change orders Responsibilities Provide Quality leadership to new product development teams in validation, design transfer, risk management, and specification development. Author master validation plans and reports. Author and execute validation protocols and reports for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning. Review the quality, validation impact, and completeness of document change order requests and equipment or facilities change controls. Determine validation strategy using an acceptable risk-based approach. Lead cross-functional teams to write PFMEAs under limited supervision. Perform process risk assessments for Non-Conformance Events and planned deviations. Maintain validation records and support cross-functional teams during New Product Introduction and Sustaining projects. Review regulatory submissions and notifications under limited supervision. Propose improvement projects using supporting data and flowcharts. Assist in updating departmental procedures and controlled documents. Evaluate specifications for new or modified process designs under limited supervision. Lead department and cross-department projects, determine QE deliverables, and help create project timelines. Participate in process design reviews, department process improvements, and department metrics reporting. Assist Quality Engineering management in Material Review Board and Production Response Team meetings. Provide management with status updates and escalate issues in a timely manner. Train new employees. Knowledge Bachelor’s degree in Science or Engineering is required. Working knowledge of CDRH, CBER, and ISO regulations, including 21 CFR Part 820, ISO 13485, and ISO 14971, is required. Working knowledge of 21 CFR Part 11 is required. Must follow all applicable FDA regulations and ISO requirements. Understanding of statistics, SPC, and acceptance sampling is required. Skills Proficient in validation methods and evaluation criteria. Experience with process validation, analytical method validation, cleaning validation, facility/utility qualification, and equipment qualification. Experience with change control processes and documentation requirements. Experience with electronic document management systems. Experience with risk analysis and PFMEA. Behavior Demonstrate Quality leadership in cross-functional and new product development settings. Work under limited supervision when leading PFMEAs, reviewing regulatory submissions, evaluating specifications, and leading department or cross-department projects. Support collaboration across teams during NPI and Sustaining projects. Communicate progress to management and escalate issues in a timely manner. Contribute to continuous improvement through departmental process improvement goals, improvement projects, and metrics support. Experience Requires 1+ years of experience in a diagnostic, medical device, biotech, or pharmaceutical company. Experience should include validation activities, change control, electronic document management systems, risk analysis, and PFMEA. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $71,000 - $105,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
ModalAI® accelerates autonomy by providing innovators with U.S.-manufactured robot and drone perception and communications systems. As a Blue UAS Framework manufacturer, we develop best-in-class autopilot and computing hardware to enable the next generation of smaller, smarter, and safer drones and robots. Robot integrators, ranging from enterprise to government, use our autopilots to accelerate autonomy across several industries. Our team of industry-leading experts in software, hardware, and mechanical engineering is passionate about technology and is shaping the future of U.S.-based drone and robot autonomy. *POSITION SUMMARY:* Production Assembly Technician UAV/UAS Technician & Systems Operator Our production team builds UAVs every day. We are looking for a highly motivated, proactive technician who loves building and flying drones to join our team in a fast-paced environment. In this role, you will work with our production, operations, and engineering teams to deliver industry-leading autonomous solutions that accelerate our customers to autonomy. *ESSENTIAL DUTIES/RESPONSIBILITIES:* * Assembling UAVs from the ground up * Flying UAVs including but not limited to: * PID Tuning * Experimental Testing * Endurance Testing * Analyzing Flight Logs * Ability to pivot and adjust quickly to changing requirements while maintaining an understanding of the technology as it changes * Researching, evaluating, and recommending solutions and technologies to improve production workflow * Integrating custom payloads including both mechanical and electrical integrations *REQUIRED SKILLS:* * 50+ hours of multi-rotor UAV flight experience * Has built multiple different UAVs in various configurations (X4, X8, Y3, Y6, Octo, Hex, etc.) * Experience with Soldering and cable assembly * Experience gathering and analyzing flight logs to determine system requirements * Experience working in a focused, dynamic, fast-paced team environment with accountable deadlines * Professional oral and written communication skills * Attention to detail and effective problem-solving skills *DIFFERENTIATORS:* * Experience with PX4/ArduPilot based Flight Controllers * FAA 107 Certified Pilot * Technical Writing Experience * Experience with Jira, Confluence or other engineering productivity suites. * 3D Printing Experience * CNC/Machine Shop Experience * Experience with Collision Avoidance Job Type: Full-time Pay: $21.00 - $28.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Flexible schedule * Health insurance * Life insurance * Paid time off * Vision insurance Application Question(s): * How many hours of soldering experience do you have? Experience: * Drone Building: 1 year (Preferred) License/Certification: * Part 107 License (Preferred) Work Location: In person
*Primary Function:* We are looking for a mid to upper-level hybrid tradesperson who is equally comfortable on the plumbing side and the pipefitting side of a mechanical project. This role leads small to mid-size service projects in commercial and industrial facilities — equipment change-outs, mechanical piping, drain/waste/vent work and lab gas improvements — and is the person on site who can carry a job from demo through start-up without handing it off between trades. This is a working lead position. You will run your own tasks, direct one to three technicians or apprentices, and coordinate directly with customers and project managers to keep work on schedule. *Typical Duties:* *Mechanical / Pipefitting Scope* Pump change-outs, including base, alignment and piping connections Cooling tower replacements and repairs Chiller and boiler replacements Fan coil and hydronic piping replacements Heating hot water, chilled water, condenser water and steam piping Small tenant improvements and lab gas improvements *Plumbing Scope* Drain, waste and vent piping, including underground and above-ceiling rework Domestic water piping, re-pipes and fixture work Water heater replacements and recirculation systems DI and RO water systems Backflow devices, grease waste and acid waste systems *Leadership on the Job* Lay out and sequence the work, order material and keep the job moving Direct and mentor technicians and apprentices across both trades Coordinate shutdowns, tie-ins and after-hours work with the customer Own job-site safety, housekeeping and daily documentation Skills, Knowledge, Qualifications, & Experience * 5+ years of commercial or industrial experience with real hands-on time in both plumbing and mechanical piping. A strong background in one trade with proven working knowledge of the other will be considered. * Drain, waste and vent experience, including layout, slope and code complianceWelding, brazing, soldering, grooved and threaded pipe experience across steel, copper and plasticAble to read plans, details and equipment submittals, and lay out work from them * Must understand and comply with all safety and OSHA requirements; OSHA 30 preferred * Valid driver's license and a clean DMV report covering the past three years * Able to work alone or lead a small crew, with excellent time management and a professional appearance and attitude * Able to communicate effectively with customers and project managers to keep projects running smoothly and on time *Bonus Qualifications* * California plumbing certification, journeyman card or completed apprenticeship in either trade * VRF, refrigeration or equipment start-up experience * Medical, laboratory or biotech facility experience, including lab gas and acid waste Pay: $80,000.00 - $115,000.00 per year Benefits: * 401(k) * Dental insurance * Health insurance * Paid time off * Vision insurance Work Location: In person
The Assembler II completes product assembly. This involves aligning parts, following work instructions, and checking that work meets quality standards. Perform work instructions to complete product assembly and according to standardized work procedures Build assemblies using work instructions, work orders, and drawings as a guide Maintain accountability for product and process quality levels and required documentation Set up equipment in preparation for production orders Receive parts and sub-assemblies in work area Complete pre-assembly work if required Document actions by completing production and quality forms Ensure that all work meets quality and safety standards and procedures while maintaining clean and safe work environment High School Diploma or GED Minimum of one (1) year of experience in area of responsibility. 2nd Shift: 3:30 PM – 12:30 AM, with shift differential pay in addition to the base hourly rate. About Frontgrade At Frontgrade, we build mission-critical electronics that perform without compromise in the world’s most demanding environments, from deep space to national defense. With decades of proven heritage, we deliver high-reliability components, subsystems, and integrated solutions trusted when failure is not an option. But our strength is not just in what we build. It is in the people who make it possible. From engineers and product managers to sales teams, marketers, and skilled manufacturing professionals, every role plays a direct part in enabling missions that protect, explore, and connect our world. We move with purpose, collaborate across disciplines, and take pride in delivering solutions our customers rely on in the highest-stakes environments. If you want your work, whatever your specialty, to contribute to something bigger, you will find your place at Frontgrade. Why Work for Us We believe mission success starts with taking care of our people. That’s why we offer competitive health, wealth, and wellbeing benefits from day one. You’ll also find real opportunities to learn, grow, and advance, whether you’re building technical expertise, leading teams, or expanding into new areas. Here, your growth is part of the mission. Additional Information This position may require access to technology, materials, software or hardware that is controlled by either ITAR or EAR U.S. export laws. As a condition of any job offer, in order to be employed in this position, you may need to obtain a U.S. Government export license(s), as required by law. Other benefits include: Immediate Medical (FSA and HSA), Dental, and Vision 401K Match with 100% immediate vesting 9X80 compressed work schedule for qualifying roles Career Opportunity and Growth Tuition Reimbursement/Student Loan Repayment Generous PTO and 11 paid Holidays per year (9 designated holidays and 2 floating holidays) 8 weeks of 100% Paid Family Leave
About Axillon Aerospace Axillon Aerospace is a leading provider of complex, highly engineered composite and polymer solutions for demanding commercial and defense applications. We are comprised of five, purpose-built centers of excellence throughout the USA and Mexico, each strategically focused on serving specific markets across aerospace engines and airframes, as well as munitions, radomes, antennas and fuel containment. Learn more at axillonaerospace.com. Summary: The Operational Excellence Specialist provides expertise in implementing the site continuous improvement plan and initiatives. Analyzes and measures the effectiveness of existing business processes and develops sustainable, repeatable and quantifiable business process improvements. Core Responsibilities: Be able to work in a team environment and demonstrate support of the Axillon Operating System lean principles; teamwork, cooperation, respect and integrity Lead continuous improvement projects such as Kaizen events, Value Stream Mapping and other Lean projects Effectively apply improvement initiatives Develop sustainable, repeatable and quantifiable process improvements Analyzes, measures and reports the effectiveness of existing manufacturing processes Assists in training and skills enhancement for all employees with respect to continuous improvement tools and techniques Provides expertise when recommending solutions to problems and implementation of corrective actions Participates in the evaluation of new technologies and determines how they can support engineering business processes Assists in maintaining a safe production environment The primary duties of this job require administrative, non-manual work directly related to business operations involving responsibility for processes and policies of significance, evaluation of possible solutions and results of the work for which the employee is responsible and making recommendations and/or decisions accordingly using professional judgment. Consistent exercise of independent judgment and discretion in matters of significance. Job Specifications: Education – Bachelor’s degree or equivalent combination of relevant education and work experience that will allow successful performance of job expectations Years Experience – 3-5 years of relevant experience Experience in Lean Manufacturing, Kaizen events, and continuous improvement techniques Familiarity/experience with continuous improvement and Six Sigma methodology Change Management experience a plus Skills – Proficient with Lean concepts and able to implement them to increase productivity and remove waste Ability to analyze data to identify projects and implement improvements Good technical writing and presentation skills Good verbal and communication skills Proficiency with computer based methods and tools Familiarity with Six Sigma and SPC principles and methods Good interpersonal skills Strong prioritization skills Ability to work well with others in the areas of teamwork and communication Ability to logically solve problems and to keep projects moving in an orderly and structured fashion Please note that the salary range information is only applicable for California. Compensation is based on a variety of factors, candidate experience, qualifications, location as well as market and business considerations. Pay Range: $85k-$90k/yr. Axillon is an Equal Opportunity Employer. Axillon is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job related reasons regardless of race, ethnicity, color, religion, sex, sexual orientation, age, national origin, disability, gender identity, genetic information, veteran status, or any other status protected by law. This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.
About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell-killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com Make an impact. Help shape the future of cell therapy. Join Artiva’s Validation team and take hands-on ownership of critical GMP qualification activities while building your expertise in a dynamic, growing biotech. Position Summary Artiva Biotherapeutics is seeking a Validation Engineer II to support qualification and validation activities for GMP facilities, utilities, equipment, computerized systems, and manufacturing processes supporting cell therapy manufacturing operations. The successful candidate will support lifecycle validation activities while ensuring compliance with FDA, EU GMP, and internal quality requirements. Experience in cell therapy, biologics, aseptic manufacturing, Annex 1 contamination control, and startup or high-growth biotechnology environments is preferred. Essential Responsibilities: Validation, Qualification, and Lifecycle Management · Author, execute, review, and approve IQ, OQ, PQ protocols and validation reports, ensuring deliverables are technically sound, compliant, and inspection-ready. · Author change controls for new equipment, system impact assessments, user requirement specifications, design qualifications, requirements traceability matrices, and other qualification deliverables as needed. · Review vendor-supplied qualification protocols before execution to identify gaps and resolve them with the vendor before work begins. · Document, investigate, and resolve discrepancies and test exceptions encountered during protocol execution; escalate to deviation or change control as appropriate. · Perform thermal mapping and requalification of controlled temperature units using wireless data loggers and associated software, including study design, data analysis, and final report authoring. · Support commissioning, qualification, startup, field verification, and testing activities for GMP manufacturing systems, utilities, facilities, and equipment. · Manage validation vendor and service provider relationships — schedule qualification activities, oversee execution, technically review vendor-supplied documentation for cGMP compliance, and drive project work to completion. · Maintain validation lifecycle documentation — status tracking, periodic review, and requalification schedules — and partner with Quality, Calibration, Facilities, and Manufacturing to ensure the asset management system reflects the current qualification, calibration, and maintenance state of every GMP instrument on campus Risk, Quality Events, and Compliance · Perform risk assessments, FMEA, system impact assessments, and component criticality determinations per ICH Q9 and ASTM E2500 to define qualification scope and justify leveraging vendor documentation where appropriate. · Own validation-related deviations, investigations, root cause analysis, and CAPAs, driving quality events to timely closure. · Evaluate quality events, maintenance activities, and proposed changes for impact to validated state, and determine whether requalification or revalidation is warranted. · Ensure compliance with FDA cGMP (21 CFR 210/211), EU GMP Annex 1, Annex 11, and Annex 15, ASTM E2500, ISPE/GAMP guidance, and internal quality systems; assess gaps against new or revised regulatory expectations and drive remediation. · Support regulatory inspections, client audits, and internal audits — including front- and back-room support, retrieval of validation records, and authoring responses to observations and findings. Cross-Functional Support · Partner with Manufacturing, Facilities, Engineering, Quality, Automation, and Regulatory Affairs on equipment onboarding, facility expansion, technology transfer, and capital projects — representing Validation in project team meetings, design reviews, and capital planning so qualification scope and timelines shape projects rather than react to them. · Support equipment onboarding end to end: specification and vendor quote review, factory and site acceptance testing, installation coordination, asset record creation, and handoff to end users. · Coordinate qualification activities around manufacturing schedules and campaign windows to minimize impact to production, and escalate schedule risk early. · Provide on-the-floor support during execution — gowning into classified manufacturing space, coordinating site access for and escorting vendor field service engineers, and troubleshooting alongside Manufacturing and Facilities. Execution work happens where the equipment is, not at a desk. · Support user training and turnover activities so systems transfer cleanly into routine GMP use with current SOPs and documentation. · Communicate validation status, risks, and open items clearly to stakeholders at all levels, and follow up persistently across departments and vendors — much of the work is tracking commitments to closure and chasing information that isn't volunteered. · Work independently on assigned tasks with general direction, escalating technical and compliance questions to senior validation staff as needed. · Adapt to shifting priorities and support off-shift, weekend, or extended-hours execution when required — qualification schedules move with vendor availability, equipment readiness, and production needs, and rework of executed documentation is a normal part of the job. Qualifications Education and Experience · Bachelor's degree in Engineering, Biotechnology, Life Sciences, Chemistry, or a related technical discipline. · 2–5 years of validation experience in a regulated GMP environment. · Experience authoring and executing qualification protocols, validation reports, and lifecycle documentation. · Working knowledge of equipment, utility, facility, process, and risk-based validation principles, including ICH Q9 and ASTM E2500. · Experience performing thermal mapping or thermal validation studies using wireless data loggers and associated software. · Experience authoring or supporting change controls, deviations, investigations, and CAPAs within a formal quality management system. · Working knowledge of FDA cGMP requirements (21 CFR 210/211) and good documentation practices. · Ability to gown and work in classified manufacturing space, and to support execution activities on the manufacturing floor. Preferred Qualifications · Experience supporting cell therapy, gene therapy, biologics, sterile manufacturing, aseptic processing, or controlled environments. · Knowledge of EU GMP Annex 1, Annex 15, ASTM E2500, ISPE guidance, 21 CFR Part 11, CSV/CSA, and contamination control strategies. · Experience qualifying cleanrooms, HVAC, environmental monitoring systems, cryogenic storage, controlled-rate freezers, biosafety cabinets, incubators, or similar GMP systems. Key Competencies · GMP validation lifecycle knowledge, technical writing, and inspection-ready documentation practices. · Risk-based problem solving, contamination control awareness, and continuous improvement mindset. · Strong collaboration, organization, and project execution skills in a fast-paced environment. · Experience maintaining asset and qualification records in a CMMS or asset management system (e.g., Blue Mountain RAM or equivalent). · Experience coordinating validation vendors and field service engineers, including protocol review and scheduling. · Experience supporting facility startup, expansion, technology transfer, regulatory inspections, or client audits in a startup or growth-stage biotechnology organization. Additional Information · Full-time position based in a GMP-regulated facility in San Diego, CA. · Occasional off-shift, weekend, or extended-hours work required to support manufacturing schedules and vendor field service availability. · On-call activities required as assigned. · Reports to Sr. Manager, Validation, Calibration and Engineering. LOCAL APPLICANTS ONLY PLEASE In addition to a great culture, we offer: · A beautiful facility · An entrepreneurial, highly collaborative, and innovative environment · Comprehensive benefits, including: · Medical, Dental, and Vision · Group Life Insurance · Long-Term Disability (LTD) · 401(k) Retirement Plan · Employee Assistance Program (EAP) · Flexible Spending Account (FSA) · Paid Time Off (PTO) · Company-paid holidays, including the year-end holiday week · Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey!
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho , we’re advancing the power of diagnostics for a healthier future for all . Join our mission as our next Senior Product Development Engineer supporting Point-of-Care. The Senior Product Development Engineer responsibilities will include but not limited to new product development, on market support, instrument development, consumable product design, assay integration into consumables, scale up, technology transfer and validation activities. This position actively participates in design teams, understands R&D goals and timelines and provides updates to leadership to ensure product launch success. The Senior Product Development Engineer also integrates engineering theory and practice within the areas of new product development, manufacturing and marketing support. This position will be onsite full-time at our San Diego (Summers Ridge) location. The Responsibilities Designs, develops and transfers new products into manufacturing Actively communicates project status, challenges, concerns and resource constraints to area management Writes reports, documents and validation protocols and maintains detailed and organized notebook records Consults on troubleshooting and aids in improvement of manufacturing processes Works with R&D Scientists to develop, automate, optimize and integrate diagnostic assays with instrumentation equipment Provides guidance to R&D as needed to prevent implementation of designs that do not meet manufacturing standards. Ensures development activities result in manufacturing processes that are robust, technically feasible, can be scaled-up, cost effective and fit within the core competencies and vision of the Operations organization. Supports the introduction of new core competencies, strives to ensure an optimized and efficient manufacturing organization. Participates in design, process development and validation, creation and implementation of documentation, and training of personnel Maintains project documentation in accordance with internal and external regulatory requirements as part of the design control process. Develops raw material in process and product specifications Perform other work-related duties as assigned. The Individual Required: Bachelor's degree with 7+ years of experience; master’s degree with 5+ years of experience in relevant engineering discipline Experience developing consumable diagnostic tests. Ability to make strategic decisions on technical issues weighing regulatory, technical, and business risks appropriately Recognized subject matter expert in one or more areas of product design Demonstrated making moderate to significant process improvements and/or implementing new processes to enhance productivity and efficiency This position is not currently eligible for visa sponsorship Ability to travel up to 10% Preferred: Experience in medical devices/diagnostics and regulated environments Experience designing products in a regulated environment Strong communication, analytical, and teamwork skills The Key Working Relationships Internal Partners: Engineering Team Program Managers Assay Development Scientists Manufacturing Team Design Quality Regulatory Affairs External Partners: Contract design and manufacturers How We Work At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact: Thrive Together – Collaborate intentionally, grow as a team Make It Happen – Focus on priorities, embrace continuous improvement Commit to Service – Cultivate a service mindset Embrace Inclusion – Be open and authentic, welcome diverse perspectives The Work Environment The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines. Physical Demands No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $130,000 to $145,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected] . #LI-TO1