Manufacturing Engineer
$90,000–$110,000 year
On-site · San Diego, California, United States
Job Summary
Manufacturing Engineer role focused on developing, improving, and sustaining manufacturing processes for regulated medical devices in a low- to mid-volume, high-mix setting. Responsibilities include leading design, development, validation, and implementation of assembly and test processes (IQ/OQ/PQ and equipment qualification), applying Built-in Quality, Lean manufacturing, and NPI for product life cycles; driving CAPA investigations, root-cause analyses, and continuous improvement initiatives (value stream mapping, standard work, visual management); serving as the manufacturing lead for NPI with DFMs, PFMEA, pilot builds, and readiness reviews; maintaining controlled documentation per ISO 13485 and FDA 21 CFR 820; managing ECOs/DCOs and MRBs; collaborating with R&D, client engineering, Quality, Production, and other stakeholders; providing mentorship and leading Kaizen events; and representing manufacturing in client audits and reviews. Requires a Bachelor’s degree in a related field, 2+ years’ experience, knowledge of Lean, 5S, PFMEA, IQ/OQ/PQ, CAPA, GMP/regulatory practices, CAD (SolidWorks), and strong cross-functional communication. On-site in San Diego, travel up to 10%.
Required Qualifications
- Bachelor's degree in mechanical, electrical or industrial engineering or equivalent
- Typically 2+ years of experience in manufacturing/engineering
- Experience with Lean manufacturing principles (5S, single-piece flow, standard work)
- Experience with PFMEA, control plans, process validation (IQ/OQ/PQ)
- Experience with root-cause analysis (8D, 5 Whys, fishbone), CAPA, SPC, Gage R&R
- Knowledge of FDA 21 CFR 820 and ISO 13485, regulatory compliance practices
- Ability to support NPI from prototype through production and engage with clients
- Proficient in CAD (SolidWorks preferred), ERP/document control systems, MS Office
- Strong communication, problem-solving, mentorship skills
- Experience with ECOs, DCOs, NCRs, MRB and configuration control
- Cross-functional collaboration with Quality, Supply Chain, Planning, Production
- Experience or ability to lead Kaizen events and RCCA investigations
- Knowledge of testing, validation, and verification methods
- Experience with design-for-manufacturability and design transfer
- Ability to translate client product requirements into manufacturable solutions
- Exposure to GMP/regulated environments (medical devices)
- Ability to travel up to 10%
- On-site work in San Diego, CA
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