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Salary: USD 120,000 - 155,000 / annual
BiVACOR is developing the world's first Total Artificial Heart, a Class III FDA-regulated active implantable device. This Senior Manufacturing Engineer role focuses on taking electrical manufacturing processes from development into validated, compliant production.
You will own electrical manufacturing process development and improvement across PCBA (printed circuit board assembly), cable/harness, controller assembly, and battery pack systems. Core responsibilities include leading 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 standards. You will investigate and resolve electrical assembly nonconformances using root cause and fault tree analysis methods, author and maintain manufacturing documentation including BOMs, work instructions, solder/crimp specifications, and test procedures, and partner with Electrical R&D, Quality, and Regulatory teams as the manufacturing engineering voice on electrical assemblies.
This is a technical ownership role requiring deep electrical engineering fundamentals and hands-on process validation expertise. You will build and defend validation packages that prove manufacturability and compliance. The role has a growth path toward broader supplier quality ownership, cross-team process leadership, and mentoring junior manufacturing engineers as the team scales.
REQUIREMENTS:
- BS in Electrical Engineering or closely related field (MS preferred)
- 5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assembly experience
- Class III or active implantable medical device experience (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
PREFERRED:
- Familiarity with IPC-610 and IPC-620 or WHMA-A-620 standards
- Exposure to supplier qualification/auditing for electronic components
- Lean/Six Sigma experience
- Experience mentoring junior engineers
