Overview

Job DescriptionJob DescriptionHelp 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 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 & StrategyDefine and execute the strategic vision for the QMS, aligned with ISO 13485, 21 CFR Part 820, 803, and 806Serve as the senior quality engineering authority for BSI surveillance audits and FDA inspectionsLead and develop a high-performing quality engineering team, providing strategic direction and career developmentEstablish enterprise-wide quality KPIs and present strategic recommendations to executive leadershipVerification, Validation & Design AssuranceDirect V&V planning, execution, and documentation for electrical, software, and system-level protocols supporting IDE and PMA submissionsApprove 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) programsManufacturing Quality & NonconformanceArchitect and enforce IPC-A-610 workmanship standards for electronic assemblies across the TAH systemOwn the nonconformance (NC) and QCIR programs, including MRB disposition, root cause investigation, and CAPA linkageDrive systemic resolution of manufacturing quality escapes with root cause rigorRisk Management & CAPALead FMEA, FTA, and risk management file strategy at the program level per ISO 14971Own and govern the enterprise CAPA process from initiation through effectiveness verificationEvaluate field performance data and clinical feedback to identify and mitigate systemic quality risksSupplier QualityArchitect and lead the end-to-end supplier quality program: qualification, performance monitoring, audits, and corrective actionsConduct strategic on-site audits with focus on high-risk and sole-source AIMD-critical suppliersPartner with engineering and procurement to assess supply chain risk and maintain the approved supplier list (ASL)Cross-Functional & Regulatory LeadershipServe as the senior quality engineering representative in executive program reviews and manufacturing readiness assessmentsLead quality engineering strategy for IDE supplements, PMA modules, and FDA information requestsInfluence a