Senior Manufacturing Engineer, Electrical Systems
Other Engineering · Full-time
Huntington Beach, CA, USA
USD 120k-155k / year
Posted on Oct 12, 2026
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.
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.
Core Responsibilities
Over time, this role has a path toward broader ownership of supplier quality, cross-team process leadership, and mentoring junior manufacturing engineers as the team scales but you won't be expected to own all of that from day one.
What We Offer
BiVACOR offers a competitive compensation package and comprehensive benefits, including:
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.
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.
Core 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
- 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)
- Exposure to supplier qualification/auditing for electronic components
- Lean/Six Sigma experience
- Experience mentoring junior engineers
Over time, this role has a path toward broader ownership of supplier quality, cross-team process leadership, and mentoring junior manufacturing engineers as the team scales but you won't be expected to own all of that from day one.
What We Offer
BiVACOR offers a competitive compensation package and comprehensive benefits, including:
- 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
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.