Staff Device Quality Engineer

Responsibilities

• Lead the application and interpretation of global regulatory standards including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45
• Architect validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity within the QMS
• Define "Compliance at Speed" frameworks to integrate Agile development with regulatory rigor
• Lead software architecture reviews to ensure safety-by-design and privacy-by-design principles
• Own risk management activities including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs
• Define and own the organization-wide Software Verification and Validation (V&V) strategy
• Govern the Design History File (DHF) from concept to commercialization
• Lead internal and external audits (FDA, Notified Body, MDSAP) as a subject matter expert
• Author and approve technical files for global submissions such as FDA 510k/De Novo, PMDA, and EU-MDR
• Mentor and develop Senior and mid-level Quality Engineers

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
• 10+ years of experience in quality engineering or product development within the medical device industry
• 3+ years in a senior or lead quality engineering role for SaMD or AI/ML-enabled products
• Deep expertise in QMS architecture and CAPA program design for SaMD
• Strong critical thinking and attention to detail
• Ability to influence without authority across engineering and regulatory leadership

Preferred Qualifications

• Master’s degree in a relevant technical or quality discipline
• ASQ Certified Quality Engineer (CQE)
• Certified Software Quality Engineer (CSQE)
• Six Sigma Black Belt

About the Company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge AI-driven, non-invasive cardiac testing technology.