Lead Electrical Manufacturing Engineer - Medical Device

Help Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. About the Role This is a high-impact technical leadership role in an FDA-regulated, Class III medical device environment, specializing in PCBA, cable and harness manufacturing, controller assembly, and battery systems. As BiVACOR's subject matter expert for electrical workmanship and manufacturing quality, you will set technical direction, lead cross‑functional teams, and help bring the world's first Total Artificial Heart to patients. Key Responsibilities Lead the design, development, and strategic improvement of electrical manufacturing processes including PCBA, cable and harness assembly, controller assembly, and battery pack build Own and lead process validations (IQ, OQ, PQ, PPQ) for all electrical manufacturing processes ensuring full FDA, ISO 13485, GMP, and IPC 610/620 Class 3 compliance Champion Lean and Six Sigma methodologies, driving measurable reductions in defects, cycle time, and rework across electrical assembly operations Lead NC/CAPA investigations for electrical assemblies, applying Six Sigma and fault tree analysis to drive root cause resolution and eliminate systemic issues Lead the qualification and development of suppliers for electrical components, PCBAs, cable and harness assemblies, batteries, and electronic sub‑assemblies Conduct supplier audits and performance reviews, driving continuous improvement across the supply base Establish and maintain comprehensive electrical manufacturing documentation including BOMs, work instructions, solder/crimp process specifications, and test procedures Lead cross‑functional collaboration with Electrical R&D, Quality, Supply Chain, and Regulatory teams as the senior manufacturing engineering voice for all electrical assemblies Mentor and develop Manufacturing Engineers at junior levels (I–III), providing technical guidance, coaching, and structured feedback Lead and manage complex, cross‑functional manufacturing engineering projects from initiation through completion What You Bring BS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering — MS desirable Medical device or other highly regulated industry manufacturing experience (Class II or III device experience preferred) 8+ years of engineering experience with a strong focus on electrical manufacturing including PCBA assembly, cable and harness manufacturing, and electronic sub‑system build IPC‑A‑610 CIS or CIT certification at Class 3 level (Required) — IPC‑A‑620 Class 3 certification strongly preferred Deep expertise in electrical process characterization, pFMEAs, IQ/OQ/PQ/PPQ, and TMVs — with a track record of owning validation programs end‑to‑end Comprehensive knowledge of ISO 13485 and FDA QSR (21 CFR Part 820) with experience supporting regulatory submissions and audits In‑depth knowledge of IPC‑610, IPC‑620, IPC‑600, J‑STD‑001, and WHMA‑A‑620 standards Advanced problem‑solving skills with structured methodology — Six Sigma Black Belt strongly preferred: PMP certification an advantage Demonstrated supplier development and management experience for electronic components and assemblies What We Offer 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off The expected salary range for this position based in Huntington Beach California is $120,000 - $155,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr BiVACOR