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Principal Device Quality Engineer

Heartflow· Quality Assurance
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Hybrid (SF Bay Area)$190k - $240kFull-timePosted 1mo ago

About the role

Global SME for software quality and design excellence, bridging Agile development with medical device regulations to ensure SaMD/AI systems are safe, secure, and compliant across the SDLC.

Responsibilities

  • Act as the primary authority on global regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45).
  • Lead integration of modern technologies into the QMS, defining validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1).
  • Partner with engineering teams to implement "Compliance at Speed" with Agile rigor.
  • Advise on software architecture with safety/privacy-by-design.
  • Support risk management activities (Hazard Analysis, Fault Tree Analysis, FMEAs for software).
  • Serve as technical lead for Software Verification and Validation (V&V) and approve test strategies, protocols, and reports.
  • Drive DHF compliance and design transfer from concept to commercialization.
  • Represent software QMS during internal/external audits (FDA, Notified Body, MDSAP).
  • Collaborate with Regulatory Affairs to author documentation for FDA, PMDA, EU-MDR.
  • Provide mentorship and technical guidance to R&D, Product, and Programs.

Qualifications

  • Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or related field (Master’s preferred).
  • 10+ years in quality engineering or product development within the medical device industry.
  • Certifications (preferred): ASQ CQE, CSQE, or Six Sigma Black Belt.

Skills

Required:Regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45)Software Architecture for safety and security-by-design

Benefits

  • Base salary $188,000 - $240,000
  • Bonus
  • Equity
Last updated Oct 5, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

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