Electrical Manufacturing Engineer

Help Us Build the Future of the Human HeartAt 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 RoleThis is a high-impact 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 ResponsibilitiesLead the design, development, and strategic improvement of electrical manufacturing processes including PCBA, cable and harness assembly, controller assembly, and battery pack buildOwn 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 complianceChampion Lean and Six Sigma methodologies, driving measurable reductions in defects, cycle time, and rework across electrical assembly operationsLead NC/CAPA investigations for electrical assemblies, applying Six Sigma and fault tree analysis to drive root cause resolution and eliminate systemic issuesLead the qualification and development of suppliers for electrical components, PCBAs, cable and harness assemblies, batteries, and electronic sub-assembliesConduct supplier audits and performance reviews, driving continuous improvement across the supply baseEstablish and maintain comprehensive electrical manufacturing documentation including BOMs, work instructions, solder/crimp process specifications, and test proceduresLead cross-functional collaboration with Electrical R&D, Quality, Supply Chain, and Regulatory teams as the senior manufacturing engineering voice for all electrical assembliesMentor and develop Manufacturing Engineers at junior levels (I–III), providing technical guidance, coaching, and structured feedbackLead and manage complex, cross-functional manufacturing engineering projects from initiation through completionWhat You BringBS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering | MS desirableMedical device or other highly regulated industry manufacturing experience (Class II or III device experience preferred)5+ years of engineering experience with a strong focus on electrical manufacturing including PCBA assembly, cable and harness manufacturing, and electronic sub-system buildDeep expertise in electrical process characterization, pFMEAs, IQ/OQ/PQ/PPQ, and TMVs — with a track record of owning validation programs end-to-endComprehensive knowledge of ISO 13485 and FDA QSR (21 CFR Part 820) with experience supporting regulatory submissions and auditsIn-depth knowledge of IPC-610, IPC-620, IPC-A-600, J-STD-001, and WHMA-A-620 standardsDemonstrated supplier development and management experience for electronic components and assembliesWhat We OfferBiVACOR offers a competitive compensation package and comprehensive benefits, including:401(k) with company matchingMedical, dental, and vision insuranceHealth Savings Account (HSA) & Flexible Spending Account (FSA)Life insurance & Employee Assistance ProgramGenerous paid time offThe 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. Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.