--- title: 'Senior Manufacturing Engineer, Electrical Systems at BiVACOR Inc' canonical: 'https://feeny.ai/job/senior-manufacturing-engineer-electrical-systems-bivacor-inc-huntington-beach-t81a0zfa2qx1' type: 'job' last_seen: '2026-09-13' --- # Senior Manufacturing Engineer, Electrical Systems at BiVACOR Inc - **Company:** BiVACOR Inc - **Location:** Huntington Beach, CA - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-09-10 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.ashbyhq.com/bivacor-inc/75021584-dd25-49b7-9580-891d1f85787b ## 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. ## About BiVACOR Inc ## Company Overview - **One-liner**: BiVACOR is a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH) using magnetic levitation technology to replace both ventricles of a failing heart. - **Entity Type**: Private (Clinical-stage, Series B-III) - **Headquarters**: Huntington Beach, California, USA (with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia) - **Founded**: 2008 - **Founders**: Daniel Timms, PhD (Founder & CTO) ## Core Business - **Primary industry**: Medical Devices / Cardiovascular Therapeutics - **Target customers**: B2B (Hospitals, Cardiac Surgery Centers, Transplant Centers); End-users are patients with end-stage biventricular heart failure awaiting a heart transplant. - **Mission or purpose statement**: "Replacing Hearts. Restoring Lives." The company is committed to addressing the global unmet need of patients with end-stage heart failure by providing a next-generation, long-term life-extending solution. ## Products & Services - **BiVACOR Total Artificial Heart (TAH)**: A clinical-stage, implantable medical device designed to completely replace the function of both ventricles of a failing heart. It is a valveless, electro-mechanical rotary blood pump that uses a single, magnetically levitated (MAGLEV) rotor to pump blood to both the body and the lungs. The device is made of titanium, has no mechanical bearings or flexing diaphragms, and is designed to be compact, durable, and powerful (capable of flows over 12 L/min). It is intended as a bridge-to-transplant for patients with end-stage biventricular heart failure. ## Market Standing - **Valuation/Market Cap**: Not publicly available (Private company). - **Key Metric**: Total funding raised is **$59.75M** (latest round: Series B-III of $9M, raised ~2 years ago). The company is currently conducting an FDA-approved Early Feasibility Study (EFS). - **Notable Investors/Partners**: Key partners include the Texas Heart Institute, Baylor St. Luke’s Medical Center, and St. Vincent’s Hospital Sydney. The company has received funding from various sources including an $18M round to move the TAH through first-in-human studies. The company has a robust collaborative network extending nationally and internationally. - **Growth Signals**: The BiVACOR TAH has been successfully implanted in five patients as part of an FDA Early Feasibility Study (EFS), with all five bridged to a donor heart transplant. The FDA has greenlit an expansion of the EFS to an additional 15 patients. The device was accepted into the FDA’s Total Product Life Cycle (TAP) Advisory Program. The first Australian implantation occurred in November 2024, with the TAH in place for over 100 days. The company received FDA Breakthrough Device Designation. ## Competitive Advantages - **Proprietary MAGLEV Technology**: The BiVACOR TAH uses a single, magnetically levitated rotor with no mechanical bearings, valves, or flexing diaphragms, eliminating mechanical wear and friction. This is a fundamental design innovation compared to traditional volume-displacement TAHs. - **Simple, Durable Design**: The device has only one moving part (the rotor), which is suspended via magnetic levitation. This simplicity is a major differentiator, promising greater long-term durability and reliability. - **Compact and Powerful**: The TAH is designed to fit most men and women (BSA >1.4 m²) and can provide high flows over 12 L/min, sufficient for an adult male during exercise. - **Regulatory Momentum**: The device has received FDA Breakthrough Device Designation, is part of the FDA’s TAP (Total Product Life Cycle Advisory) Program, and has successfully completed a first-in-human Early Feasibility Study (EFS) with all five patients bridged to transplant. The EFS has been expanded to an additional 15 patients. ## Strategic Focus - **Clinical Validation & Regulatory Approval**: The primary focus is on completing the expanded Early Feasibility Study (EFS) and progressing toward a pivotal study and eventual FDA premarket approval (PMA). - **Global Expansion**: Following successful implants in the US and Australia, the company is building a global footprint and clinical evidence base. - **Commercialization Preparation**: With the appointment of a new CEO (Jim Dillon, a veteran medical device executive) and acceptance into the FDA’s TAP program, the company is preparing for eventual commercialization and market entry. ## Why Work Here - **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. ## Sources 1. [bivacor.com](https://bivacor.com/) 2. [bivacor.com/careers](https://bivacor.com/careers/) 3. [bivacor.com/news](https://bivacor.com/news/) 4. [cbinsights.com](https://www.cbinsights.com/company/bivacor) 5. [jobs.ashbyhq.com](https://jobs.ashbyhq.com/bivacor-inc) ## Other roles at BiVACOR Inc - [Manufacturing Technician](https://feeny.ai/job/manufacturing-technician-bivacor-inc-huntington-beach-0m2p6qhe2gb9) — Huntington Beach, CA - [Director of Verification & Validation](https://feeny.ai/job/director-of-verification-validation-bivacor-inc-huntington-beach-04c3k4gr3wcp) — Huntington Beach, CA - [QC Inspector](https://feeny.ai/job/qc-inspector-bivacor-inc-huntington-beach-10ds4q14h6y2) — Huntington Beach, CA - [Manufacturing Engineer III](https://feeny.ai/job/manufacturing-engineer-iii-bivacor-inc-huntington-beach-kd20ph98pjha) — Huntington Beach, CA - [Principal Manufacturing Mechanical Engineer](https://feeny.ai/job/principal-manufacturing-mechanical-engineer-bivacor-inc-huntington-beach-azrjvx8b06hw) — Huntington Beach, CA - [Manufacturing Technician](https://feeny.ai/job/manufacturing-technician-bivacor-inc-huntington-beach-beg229xfp394) — Huntington Beach, CA - [Field Clinical Engineer](https://feeny.ai/job/field-clinical-engineer-bivacor-inc-united-states-3tmw4ew29945) — United States - [Senior Manager, Quality Engineering](https://feeny.ai/job/senior-manager-quality-engineering-bivacor-inc-huntington-beach-6h4qe4xekz41) — Huntington Beach, CA - [Field Clinical Specialist](https://feeny.ai/job/field-clinical-specialist-bivacor-inc-united-states-2vpx8py6bbb8) — United States - [Clinical Training & Educational Specialist](https://feeny.ai/job/clinical-training-educational-specialist-bivacor-inc-huntington-beach-emsva4a9ge9k) — Huntington Beach, CA