Senior Manufacturing Engineer, Electrical Systems BiVACOR Inc Huntington Beach, CA Job Details Full-time $120,000 - $155,000 a year 20 hours ago Benefits Health savings account Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Regulatory compliance Bachelor's degree in engineering Production validation processes Medical device manufacturing facility experience Electrical engineering training Biomedical regulatory compliance Biomedical manufacturing processes

ISO 13485 FDA

regulations Full Job Description 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.

Compensation Range:

$120K - $155K