About the RoleThis 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 ResponsibilitiesQuality 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
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