BiVACOR is a privately held company founded in 2008. Their staff includes world-class engineers, medical specialists, and business executives who are diligently working to advance this ground-breaking technology. Backed by Innovation Bay.
About the role
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.
What they're looking for
- 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
- Familiarity with IPC-610 and IPC-620 or WHMA-A-620 (we'll support depth here on the job)
More about this role
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.
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,...
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