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
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
What You Bring — Required
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
What You Bring — Preferred (not required to apply)
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
What This Role Grows Into
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
The 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.