Senior Manager, Quality Engineering

About the Company

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.

Responsibilities

• 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
• Direct V&V planning, execution, and documentation for electrical, software, and system-level protocols
• Oversee test method validation (TMV) and equipment qualification (IQ/OQ/PQ) programs
• Architect and enforce IPC-A-610 workmanship standards for electronic assemblies
• Own the nonconformance (NC) and QCIR programs, including MRB disposition and CAPA linkage
• Lead FMEA, FTA, and risk management file strategy per ISO 14971
• Architect and lead the end-to-end supplier quality program
• Lead quality engineering strategy for IDE supplements, PMA modules, and FDA information requests

Requirements

• Bachelor’s degree or higher in Electrical Engineering
• Minimum 18 years of experience in the medical device industry
• Demonstrated senior quality engineering leadership
• Direct experience with Class III Active Implantable Medical Devices (AIMD)
• Deep knowledge of FDA IDE/PMA regulatory requirements
• Expert knowledge of IEC 60601, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806
• Proficiency in FMEA, FTA, statistical analysis, and MSA/Gage R&R

Preferred Qualifications

• IPC-A-610 and/or IPC-A-620 certification
• 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