--- title: 'Senior Manager, Quality Engineering at BiVACOR Inc' canonical: 'https://feeny.ai/job/senior-manager-quality-engineering-bivacor-inc-huntington-beach-6h4qe4xekz41' type: 'job' last_seen: '2026-09-13' --- # Senior Manager, Quality Engineering at BiVACOR Inc - **Company:** BiVACOR Inc - **Location:** Huntington Beach, CA - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-05-28 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.ashbyhq.com/bivacor-inc/efee1019-b3d6-4830-94ea-af83e579fb76 ## Job description Help Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients a second chance at life. If that's the kind of work that gets you out of bed in the morning, we'd love to meet you. ## About the Role This is a high-impact leadership role at the intersection of quality engineering strategy and clinical-stage medical device development. As Senior Manager, Quality Engineering, you will serve as a principal leader within the BiVACOR quality organization, responsible for architecting and directing quality engineering functions across the full product lifecycle of the Total Artificial Heart (TAH) system, one of the most technically advanced implantable devices in development today. This elevated role demands a visionary, technically authoritative, and operationally excellent leader with deep expertise in electrical engineering and a distinguished track record with Class III Active Implantable Medical Devices (AIMD). You will not only lead the QE team in verification and validation, manufacturing process quality, supplier controls, and regulatory compliance — you will define the strategic direction of quality engineering programs, drive enterprise-level QMS maturity, and serve as a senior executive liaison across quality, engineering, manufacturing, regulatory affairs, and clinical functions. You will mentor and grow quality engineering talent, shape organizational quality culture, and partner with senior leadership to advance BiVACOR’s mission of bringing a life-saving total artificial heart to patients. ## Key Responsibilities Quality System Leadership & Strategy - Define and execute the strategic vision for the QMS, aligned with ISO 13485, 21 CFR Part 820, 803, and 806 - Serve as the senior quality engineering authority for BSI surveillance audits and FDA inspections - Lead and develop a high-performing quality engineering team, providing strategic direction and career development - Establish enterprise-wide quality KPIs and present strategic recommendations to executive leadership Verification, Validation & Design Assurance - Direct V&V planning, execution, and documentation for electrical, software, and system-level protocols supporting IDE and PMA submissions - Approve test protocols and reports, ensuring traceability to design inputs and applicable standards (ISO 14708, IEC 60601, ISO 14971) - Oversee test method validation (TMV) and equipment qualification (IQ/OQ/PQ) programs Manufacturing Quality & Nonconformance - Architect and enforce IPC-A-610 workmanship standards for electronic assemblies across the TAH system - Own the nonconformance (NC) and QCIR programs, including MRB disposition, root cause investigation, and CAPA linkage - Drive systemic resolution of manufacturing quality escapes with root cause rigor Risk Management & CAPA - Lead FMEA, FTA, and risk management file strategy at the program level per ISO 14971 - Own and govern the enterprise CAPA process from initiation through effectiveness verification - Evaluate field performance data and clinical feedback to identify and mitigate systemic quality risks Supplier Quality - Architect and lead the end-to-end supplier quality program: qualification, performance monitoring, audits, and corrective actions - Conduct strategic on-site audits with focus on high-risk and sole-source AIMD-critical suppliers - Partner with engineering and procurement to assess supply chain risk and maintain the approved supplier list (ASL) Cross-Functional & Regulatory Leadership - Serve as the senior quality engineering representative in executive program reviews and manufacturing readiness assessments - Lead quality engineering strategy for IDE supplements, PMA modules, and FDA information requests - Influence and align R&D, Regulatory Affairs, Software, and Manufacturing Engineering on quality strategy throughout the product lifecycle Continuous Improvement - Define and lead the organizational continuous improvement strategy using Lean, Six Sigma, or equivalent methodologies - Sponsor initiatives to reduce defect rates, improve first-pass yield, and optimize QMS processes - Present improvement initiative outcomes and strategic impact to executive leadership ## What You Bring - Bachelor’s degree or higher in Electrical Engineering (mandatory) - Minimum 18 years of experience in the medical device industry, including demonstrated senior quality engineering leadership - Direct experience with Class III Active Implantable Medical Devices (AIMD), including deep knowledge of FDA IDE/PMA regulatory requirements - IPC-A-610 and/or IPC-A-620 certification strongly preferred Technical Expertise - Expert knowledge of IEC 60601 series, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806 - Deep experience with electrical and electromechanical system qualification for implantable devices - Proficiency in FMEA, FTA, statistical analysis, MSA/Gage R&R, and reliability methodology - Experience with EO sterilization qualification, cleanroom operations, and QMS software platforms Leadership & Influence - Proven track record of building and inspiring senior quality engineering teams - Demonstrated ability to influence executive stakeholders and drive enterprise-level quality strategy - Experience representing quality at a senior level in FDA or notified body inspections - Track record of leading cross-functional V&V programs for complex regulatory submissions Highly Desirable - VAD or Total Artificial Heart experience - ASQ certification (CQE, CQM/OE, or CRE) - Familiarity with Enlil, Arena, or comparable QMS/PLM platforms - Experience with IDE clinical studies and associated quality system requirements The expected salary range for this position based in Huntington Beach California is $155,000 - $169,990. 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. 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