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1 month ago

Manufacturing Engineer 1

Hologic - San Diego, CA 92121

Why Hologic? At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health. None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities. What to expect: Provides engineering support for troubleshooting, modifying equipment and processes Supports equipment mechanics, technicians and manufacturing leads Create and/or modifies equipment maintenance procedures Writing and reviewing operating procedures, documents and reports Performs equipment, process and product performance testing Support equipment Installation, Operation, and Performance Qualification Validations Reviews and approves calibration datasheets, work orders, PM’s and change controls What we expect: Working knowledge of microprocessor controls, utility distribution systems and process engineering Basic knowledge of manufacturing automation systems and best design practice Knowledge of CGMPs, ISO 13485 and FDA 21 CFR 820 Working knowledge of Windows based programs SolidWorks or Pro/E (3D modeling knowledge) MS Office and MS Project Education & Experience: BS degree in Mechanical, Bio, Chem, or Electrical Engineering 1-2 years of related industry experience The annualized base salary range for this role is $71,500 to $105,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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-PR1

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1 month ago

Senior/Staff Process Development Engineer – Laser Manufacturing

REVA Medical, LLC - San Diego, CA 92111

Position Summary The Senior / Staff Process Development Engineer will lead development, characterization, validation, and implementation of laser cutting processes supporting REVA's bioresorbable scaffold platform. This is a hands-on role responsible for process characterization, equipment qualification, process validation, supplier process development, manufacturing implementation, and regulatory submission support. The successful candidate will work closely with Manufacturing, Quality, Regulatory Affairs, R&D, and supplier partners to establish robust, scalable, and compliant manufacturing processes. Please note: Relocation assistance and visa sponsorship are not available for this role. Key Responsibilities Lead development, characterization, optimization, and validation of laser cutting processes for polymer medical devices. Develop and execute equipment qualifications, including IQ, OQ, and PQ protocols and reports. Design and execute process characterization studies, DOE activities, and process capability analyses. Develop manufacturing procedures, work instructions, process specifications, and inspection methods. Lead technical activities supporting regulatory submissions, including process characterization, validation, technical justifications, and responses to regulatory questions. Collaborate with equipment vendors and manufacturing partners to develop, optimize, and maintain manufacturing processes. Support supplier qualification, supplier process development, and manufacturing readiness activities. Troubleshoot manufacturing equipment and processes using data-driven problem-solving methods. Support risk assessments, change controls, investigations, CAPAs, and engineering studies. Qualifications BS degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Materials Engineering, or related discipline. Senior Engineer: 5+ years of relevant experience. Staff Engineer: 10+ years of relevant experience preferred. Experience developing and validating manufacturing processes in a regulated industry, including IQ/OQ/PQ, DOE, and statistical analysis. Experience working with manufacturing equipment vendors and external suppliers. Medical device manufacturing experience preferred. Experience with laser cutting or laser processing technologies preferred. Hands-on experience developing or supporting laser cutting processes for stents, vascular scaffolds, hypotubes, polymer tubing, or other precision medical device components strongly preferred. Polymer processing experience preferred. Experience supporting FDA-regulated products preferred. Work Environment Combination of office, laboratory, and manufacturing floor environments. Significant hands-on interaction with manufacturing equipment and process development activities. Must follow laboratory and manufacturing safety protocols and wear PPE as required.

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1 month ago

Process Engineer I

NEOTech - Carlsbad, CA 92011

Summary: Improves manufacturing processes through work flow improvements and automation. Works closely with employees at all levels to learn process and determine critical points. Hands on implementation, evaluations and data collection. Essential Duties and Responsibilities include the following: Responsible for facilitating transformation efforts (Kaizen) to deliver Key Performance Indicator (KPI) and Profit & Loss (P&L) improvement results. Responsible for the successful implementation of continuous improvement projects within the Mason Location Operations. Reports project updates and results by creating and delivering presentations in MS PowerPoint. Champions improvements thru transformation of operating systems, management infrastructure, and mindset, behavior, and capabilities using “Lean Manufacturing” concepts. Drives issues to closure through project management processes and collaboration with other departments. Assists in creating process flow and business process requirements documentation; establishes operating equipment specifications. Provides hands-on technical and process support to operations. Improves manufacturing techniques and process capabilities. Troubleshoot production problems and provides timely corrective and preventive actions. Maximizes efficiencies and yields at low cost while maintaining product quality. Provides support and leadership for projects. Responds to business and customer needs. Other duties, as assigned. Job Knowledge, Skills & Abilities: Minimum of 2-3 years of experience in a manufacturing work environment Prior Lean Manufacturing experience is preferred Demonstrated ability to drive cross functional teams to solve problems and implement sustainable improvements within the organization. Excellent verbal & written communication skills required to communicate at all levels of the organization (front-line to management) required. Leadership, interpersonal skills, initiative, creativity and ability to work independently required. Able to apply, teach, and coach teams on the use of Lean Six Sigma concepts of Visual Management, SMED, 5S, root cause analysis, value stream mapping, FMEA, Pareto charts, and histograms. Project management skills. Demonstrated software skills with MS Excel and MS PowerPoint required. Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) is required. Knowledge of Macros is a plus. Education and/or Experience: B.S. in Engineering, Science or Math. 2-3 years of contract manufacturing experience within the Electronics Industry . Preferred 1, or more, years of experience in: LTCC, HTCC, thick-film processing, or ceramic manufacturing Experience working within CFT (Customer Focused Team) Structure Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen or U.S. Permanent Resident. Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match. NEOTech is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment. We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company’s equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace. Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.

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1 month ago

Quality Engineer III

NEOTech - Carlsbad, CA 92011

Summary: The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interacting with other departments, suppliers, and customers on technical and quality matters for process improvement. Responsible for maintenance, improvement, and compliance to the Quality Management System (QMS) to meet customer requirements, regulatory and compliance requirements, quality standards, company goals and objectives. Essential Duties and Responsibilities: Adhere to all FOD requirements Mentor, assist, and develop other quality engineers Lead continuous improvement (kaizen) efforts and engage area employees to participate Participate in leading new product introduction (NPI) efforts. Lead the resolution of high-profile technical projects and problems that have customer-affecting implications. Lead continuous quality initiatives and recommend solutions both tactically and strategically. Support production and quality team in quality and process control improvements Use quality tools to analyze quality data and conduct a periodic quality meeting with internal team and customer for process improvement. Lead a cross-functional problem-solving team and implement quality tools & techniques to overcome barriers to continuous quality improvements. Continually look for improvement and make appropriate recommendations. Manage DMR, MRB, RMA, and CAPA processes to ensure they are compliant with company procedures. Oversee the Corrective Action/Preventative Action (CAPA) process. Initiate CAR/8D into an internal team or supplier and follow up until it is closed. Review customer data for quality clauses and conformity and respond to customer quality feedback. Support incoming inspection and provide guidance for MSA & AQL. Perform risk assessment for quality process including FMEA. Create and maintain QMS documentation to meet the company, regulatory and compliance requirements. Participate in annual internal audits for ISO 9001 and AS 9100. Issue Quality Alert and participate in Purge process. Ensure that all production critical supplier issues are resolved in a timely manner, and corrective actions are implemented correctly Support all Lean Six Sigma initiatives/programs Perform all other duties, as assigned Job Knowledge, Skills & Abilities: Knowledge of ISO 9001 and AS 9100 Experience in LTCC, HTCC, thick-film processing, or ceramic manufacturing preferred Understanding of IPC-A-610m, J-STD-001 and MIL-STD-883/ MIL-PRF-38534 requirements. Strong ability to quickly learn production processes to understand and resolve complex manufacturing issues Must be able to interface, coach, guide and mentor floor personnel and provide clear constructive directions Experience of dealing directly with customers regarding quality issues with a service mindset Ability to interpret all customer documents and related specifications Excellent organizational skills, attention to detail and ability to work independently Ability to handle multiple tasks simultaneously and prioritize based on deadlines Adaptability to change, open to new ideas, takes on new responsibilities, handles pressure, and adjusts plans to meet changing needs Corrected vision with the ability to work with fine tools under a microscope Ability to work in a production environment wearing a smock, hairnet and face mask as required Possess a strong sense of urgency, successful in meeting company quality and production objectives Experience/Education: Associate degree in Engineering or on-the-job training in electronics or electrical engineering. B.S. Degree in Electrical, or Manufacturing Engineering preferred. At least 5+ years of related experience required in a quality organization working preferably within a contract manufacturing environment. Knowledge of lean and six sigma methodologies preferred Understanding of common electronic manufacturing documentation Effective use of common electronic manufacturing equipment such as oscilloscopes, meters, power supplies, PLD programmers, etc. Experience working for an ISO9000 or AS9100 accredited organization Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen or U.S. Permanent Resident. Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match. NEOTech is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment. We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company’s equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace. Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.

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1 month ago

Process Engineer III

NEOTech - Carlsbad, CA 92011

Summary: Support current manufacturing processes related to LTCC manufacturing including, but not limited to: Developing and refine LTCC fabrication processes including Green tape handling Via punching and filling Screen printing (conductors, resistors, dielectrics) Layer stacking and lamination Binder burn-out and co-firing (sintering) Optimize furnace profiles to control shrinkage, warpage, and defects. Establish/Update process document standard operating procedures (SOPs). Essential Duties and Responsibilities: Program, troubleshoot & maintain manufacturing process equipment as required as referenced in the summary section. Support engineering initiatives in evaluating: print pastes, new equipment (installations) and recommends solutions both tactically and strategically. Initiate process improvements through effective evaluations of test/yield data and manufacturing defects and make adjustments to process equipment accordingly. Create, present, and obtain approval for capital investment programs. Work with Production to develop and direct opportunities that affect revenues, costs and processes. Prepares and submits reports, as required. Provides guidance to machine operators/production employees and shows alternate methods of solving or preventing process, business, or technical problems. Interacts with other functional and business groups or with outside vendors. Complies with Environmental Health and Safety regulations. Support and follow all ISO standards related to OnCore’s various Quality Management Systems. These systems may include, but are not limited to, quality, the environment, health, safety and security. Support all corporate and site 6S objectives. Perform all other duties, as assigned Experience/Education: B.S. in Engineering, Science or Math 5, or more, years of contract manufacturing experience within the Electronics Industry 3, or more, years of experience in: LTCC, HTCC, thick-film processing, or ceramic manufacturing Experience working within CFT (Customer Focused Team) Structure Skills/Knowledge Knowledge of ceramic substrate manufacturing processes, including tape casting, laser machining, screen printing, metallization, lamination, firing, and brazing. Understanding of technical documentation, manufacturing travelers, process specifications, and revision control requirements. Familiarity with inspection techniques, dimensional measurement tools, and quality standards for ceramic substrates and microelectronic assemblies. Knowledge of cleanroom practices, handling requirements for ceramic materials, and ESD-controlled manufacturing environments. Understanding of defect identification related to ceramic substrates, including cracks, chips, delamination, metallization defects, and warpage. Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen or U.S. Permanent Resident. Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match. NEOTech is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment. We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company’s equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace. Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.

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1 month ago

Assembler II

NEOTech - Carlsbad, CA 92011

Perform inspection of product run through Automated Optical Inspection equipment as it is manufactured on the SMT line. Essential Duties and Responsibilities: Adhere to all ESD requirements and Board Handling. Use of Moisture Sensitive Device (MSD) handling requirements based on the components moisture sensitive levels (MSL). Verify product compliance to workmanship standards as documented in work instructions. Verify process compliance to established AOI programs. Verify integrity of data collected by machinery. Communicate defects not captured by equipment to responsible personnel for enhancement of program integrity. Communicate to assembly operators defects being noted during the AOI program review. Support and follow all ISO standards related to NEOTech's various Quality Management Systems. These systems may include, but are not limited to, quality, the environment, health, safety and security. Support all corporate and site 6S objectives. Perform all other duties, as assigned. Job Knowledge, Skills, Qualifications & Abilities: • Ability to utilize electronic manufacturing systems • Computer proficiency. • Knowledge of Automated Optical Inspection equipment and procedures. • Pass IPC-DVD-64C Component Identification. • Pass IPC-A-610 Modules 1, 2, 4, 5, 7 & 8 workmanship standards. • Ability to support a minimum of 4 customer products while maintaining quality and production standard requirements • Ability to work on multiple tasks using a wide range of procedures with a minimum mid-level complexity. • Ability to follow established procedures on routine work and provide valuable feedback on continuous improvement opportunities. • A minimum of 1+ years related experience or vocation or technical certificate without related experience. • Ability to successfully train and develop Level I operators. • Mastery of all operator Level I essential duties Experience/Education: • High School Diploma /GED or equivalent experience preferred • Experienced using Windows operating systems including Microsoft Office products • Experience working for an ISO9000n or AS9100 accredited organization is a plus Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match. NEOTech is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment. We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Companys equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace. Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.

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1 month ago

QA Technician (1st Shift)

SUJA Juice - Oceanside, CA 92056

Position Summary The Quality Assurance Technician ensures food safety, quality, and compliance across all production activities. This role is critical in supporting manufacturing by identifying risks, conducting inspections, and verifying that all regulatory and Suja standards are met. This is an on-site position within a production environment and reports to the QA Supervisor. Schedule 5:00 AM – 1:30 PM Tuesday–Saturday with flexibility for overtime as needed. Sunday–Thursday with flexibility for overtime as needed. Essential Duties and Responsibilities Monitor production conditions, specifications, process controls and tracking controls Monitor wash line concentrations and test ppm concentrations for sanitation bucket and floor solutions Monitor a system that will verify checks on existing production control forms and be audited on the same forms that meet all program requirements. Collect Lab retain samples Verify all CCPs on-line and take corrective actions whenever necessary to assist in determining the root cause and development of a preventative action plan Responsible for checking the pH levels, temperature and brix of each batch of juice produced and is with in product specifications Verify and document Facility Operation Inspections & Good Manufacturing Practices Enforce Good Manufacturing Practices (GMPs) throughout the manufacturing areas Perform Standard Sanitation Operational Procedures (SSOPs) verification and ATP swabs Tracks non-conforming product (Holds) Perform pre-operational inspection procedures of all production/bottling equipment and facility Verify equipment calibrations. Verify volumes, lot codes, torques & bottle weights are within product specification. Complete and enter into database all pallet tags and CCP forms for production and bottling. Record cycles and verify that all HPP settings and information is correct Perform metal mesh, magnet and sock mesh inspections Verify production lot codes, labels, mold number and packaging are within product specification Shipping and receiving verifications. Verification of all raw materials being delivered and labelled with accurate information at Receipt (product name, lots, expirations, quantity received) COA Reviewing, comparing to the specification, approving and filing the COA. Escalating or placing on hold any items that are out of compliance. Review and Verify receiving documents and logs. Monitors production conditions, specifications, process controls and tracking controls as they specifically relate to raw materials used in production. Document and maintain records for all raw materials used in the production process including disposals, usage, and pre-batching of ingredients. Materials will be logged on the appropriate batch ticket for raw material commodity of interest. Commodities include raw produce, frozen juice, frozen puree, dry ingredients and aseptic products. Inspect raw materials for deficiencies relating to appearance, texture, and/or odor before production use. Inspect incoming trailers to ensure compliance with receiving standards. Report any food safety problems to the SQF Practitioner or Department Supervisor in a timely manner so that corrective actions may be performed. Job Qualifications 1–2 years of experience in Quality Control and/or the food industry preferred Familiarity with food safety regulations is a plus Other Skills & Abilities Excellent communication skills Strong computer proficiency Sharp critical thinking and problem-solving abilities Flexible and able to adapt to change Capable of working independently with moderate supervision Comfortable in a fast-paced production setting Working Conditions This role operates in a food manufacturing environment. Frequent standing, walking, and exposure to cold or wet areas are expected. Compensation and Benefits Come thrive at Suja Life! We offer a competitive benefits package, including: Hourly Pay: $20.00 Medical, dental, vision, life insurance, and more 401(k) match to help you plan for the future Paid time off: vacation, sick days & holidays Juice benefits: yes, we keep you fueled and refreshed! #ZR #INDHP Suja Life is proud to be an equal-opportunity employer seeking to create a welcoming and diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, ancestry, physical or mental disability, medical condition, marital status, genetics, age, or veteran status or any other applicable legally protected status or characteristic. The Company complies with all federal/local/state regulations regarding pay. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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1 month ago

Welder I

Magnaflow - Oceanside, CA 92056

Who are we: Magnaflow is a leading manufacturer and supplier based in Oceanside, CA of premium products to the automotive aftermarket industry such as catalytic converters, performance exhaust and replacement exhaust. Through the Camburg division in Huntington Beach, CA. Magnaflow also supplies race-inspired performance suspension products and vehicle uplifting services, Magnaflow is focused on future growth through both new business development and new product introduction. Our websites are www.magnaflow.com and www.camburg.com. Salary Range: $22-$28 USD *Final agreed upon compensation will be based on a variety of factors including but not limited to an individual’s related experience, education, certifications, skills, and work location. What you will be doing: Entry-level welding classification responsible for foundational welding operations under supervision. Requires demonstrated competency in setup parameters, weld quality standards, and safe equipment use. Responsibilities: Perform touch-up welding to correct minor weld defects per quality standards Execute internal welding operations on assemblies per work instructions Perform hand welding operations using MIG/GMAW or similar processes Set up welding equipment using approved parameters Inspect own work against visual weld criteria Maintain work area cleanliness and comply with all PPE requirements Complete documentation accurately per Welding Shop Router Perform other duties as required Requirements: High school diploma or equivalent (some positions may require a technical welding certification or degree). Previous experience in a manufacturing or welding environment is typically required, though on-the-job training may be provided. Minimum of 5 years is preferred in welding stainless-steel products and is familiar with the MIG welding process What you need: Ability to read and follow work instructions and controlled documents. Basic math and measurement skills. Basic knowledge of OSHA safety regulations. Maintain accurate counts of parts produced daily. Maintain a functional work area that is consistent with Five “S” and Lean Manufacturing principles. Inspect parts produced to the company’s quality standards, and fitment to the fixture. Close and general vision. Good hand eye coordination. Prolonged standing of up to 8 hours at a time. Requires the lifting of 50 lbs. Any lifting over 50 lbs. is to be lifted with the assistance of other individuals. Requires reaching above and below the shoulders. Welding helmet. PPE (Steel toe shoes, safety glasses, gloves, earplugs, etc.). What’s in it for you? Competitive Salary PTO, Sick Pay, Birthday Holiday, Paid Holidays Medical, Dental, Vision 401k Matching (Up to 5%) Education assistance Company sponsored events Growing department and team #LI-Onsite

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