Principal Device Quality Engineer
Core
Global subject matter expert for software quality and design excellence, bridging rapid Agile development with rigorous medical device regulations for AI/ML-enabled digital health solutions.
Role type
Principal Device Quality Engineer (Software & AI/ML focus)
Builds
AI-driven non-invasive cardiac test software (Heartflow FFRCT Analysis, RoadMap Analysis, Plaque Analysis) and SaaS cloud infrastructure
Domain
Medical Device / Digital Health / Cardiovascular AI
Deliverable
production ML models | product features | infrastructure
Required skills
Software quality engineering, medical device regulations (IEC 62304, ISO 13485, ISO 14971), AI/ML validation frameworks, cybersecurity (ISO 81001-5-1), risk management (FTA, FMEA), Software Verification and Validation (V&V), Design History File (DHF) management, regulatory submission documentation
Preferred skills
ASQ CQE, CSQE, Six Sigma Black Belt, Master's degree in Software Engineering/Computer Science/Biomedical Engineering
Technologies
AI/ML, Cloud Infrastructure (SaaS), Cybersecurity frameworks
Responsibilities
Lead integration of modern technologies into Quality Management System (QMS), advise on software architecture for safety/security/privacy, represent organization during FDA/Notified Body audits, author technical documentation for global regulatory bodies, mentor R&D and Product teams
Seniority
Principal, strategy & mentorship
