Senior Manufacturing Engineer, Electrical Systems at BiVACOR Inc (Huntington Beach, CA)
BiVACOR Inc· Huntington Beach, CA·
Role details
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.
Why work at BiVACOR Inc
- Mission-Driven Work: Employees directly contribute to a life-saving technology that addresses a critical global unmet need for patients with end-stage heart failure.
- World-Class Team: Work alongside leading biomedical engineers and renowned cardiac surgeons, including pioneers in the field of artificial hearts.
- Innovative Technology: Be at the forefront of a paradigm shift in artificial heart design, working with cutting-edge MAGLEV and rotary blood pump technology.
- Culture: The company emphasizes collaboration, hard work, and recognizing team members. It is described as having a "highly driven and performing team" with a "robust collaborative network."
- Remote/Hybrid/Office Policy: Not explicitly stated, but the company has multiple physical office locations (Huntington Beach, CA; Houston, TX; Gold Coast, Australia), suggesting an on-site or hybrid model is likely for engineering and lab roles.
- Benefits & Perks:
- Health: Medical (HMO/PPO options with fully employer-funded premiums for some plans), Dental, Vision, Short-term & Long-term Disability.
- Time Off: Generous vacation (80 hours in year one, increasing to 136 hours by year 7) plus an additional 80 hours of PTO per year.
- 401(k): 4% non-elective employer contribution (immediately vested after 90 days) plus an elective employer match up to 6%.
- Incentives: Short-term and long-term incentive plans are part of the benefits package.
- Culture: Described as collaborative, hard-working, and focused on recognizing team members. The company is an equal opportunity employer committed to an inclusive environment.