Senior Manufacturing Engineer, Electrical Systems
About The Position
BiVACOR is building the world's first Total Artificial Heart, a Class III, FDA-regulated active implantable device. We're looking for a Senior Manufacturing Engineer who combines strong electrical engineering fundamentals with hands-on process validation ownership, to help take our electrical manufacturing (PCBA, cable/harness, controller assembly, battery systems) from development into validated, compliant production. This is a technical ownership role, not a generalist one: we need someone who can look at a board, harness, or controller assembly and understand it at the electrical level, and who can build and defend the validation package (IQ/OQ/PQ/PPQ) that proves it's manufacturable and compliant.
Requirements
- BS in Electrical Engineering (or closely related field); MS a plus
- 5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assembly
- Class III (or active implantable) medical device experience; this is required, not preferred
- Direct, hands-on ownership of process validation: IQ/OQ/PQ/PPQ, pFMEA, or test method validation
- Working knowledge of ISO 13485 and FDA QSR
Nice To Haves
- Familiarity with IPC-610 and IPC-620 or WHMA-A-620 (we'll support depth here on the job)
- Exposure to supplier qualification/auditing for electronic components
- Lean/Six Sigma experience
- Experience mentoring junior engineers
Responsibilities
- Own electrical manufacturing process development and improvement across PCBA, cable/harness, controller, and battery pack assembly
- Lead process validation (IQ/OQ/PQ/PPQ) and test method validation for electrical manufacturing processes, ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485
- Investigate and resolve electrical assembly nonconformances (NC/CAPA) using root cause and fault tree methods
- Author and maintain manufacturing documentation: BOMs, work instructions, solder/crimp specs, test procedures
- Partner with Electrical R&D, Quality, and Regulatory as the manufacturing engineering voice on electrical assemblies
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
