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Senior Device Quality Engineer

Heartflow· Quality Assurance
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Hybrid (San Francisco Bay Area)$160k - $180kFull-timePosted 2mo ago

About the role

Senior Device Quality Engineer leading software quality and design excellence for SaMD and AI/ML-enabled technologies, bridging Agile development with medical device regulatory requirements within Heartflow’s Software Development Lifecycle.

Responsibilities

  • Technical Leadership
  • Standards Execution: Apply global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities.
  • SDLC Support: Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS).
  • Agile Integration: Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases.
  • Design Quality & Risk Management: Participate in software architecture reviews to ensure safety-by-design and privacy-by-design principles.
  • Risk Analysis: Facilitate and document comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs.
  • V&V Execution: Lead Software Verification and Validation (V&V); develop and execute test strategies, protocols, and reports to ensure product performance.
  • Execution & Compliance: Manage the Design History File (DHF) from concept to commercialization; audit-ready documentation and seamless design transfer.
  • Audit Support: Support internal and external audits (FDA, Notified Body, MDSAP) as a subject matter expert for software processes.
  • Cross-Functional Collaboration: Support Regulatory Affairs in authoring technical files for FDA (510k/De Novo), PMDA, EU-MDR; provide technical coaching and quality training to R&D and Product teams.

Qualifications

  • Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
  • 5–8 years of experience in quality engineering or product development within the medical device industry
  • Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt

Skills

Required:Regulatory standards comprehensionQuality Management System (QMS)Software Verification & Validation (V&V)Risk Management (Hazard Analysis, FTA, Software FMEAs)Audit and regulatory submissions

Benefits

  • Base salary: $160,000 - $180,000
  • Bonus
Last updated Sep 14, 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.

CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
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