Staff Device Quality Engineer
Core
Senior technical authority for software quality and design excellence, bridging rapid Agile development with rigorous medical device regulations to ensure SaMD and AI/ML solutions are safe, secure, and compliant.
Role type
Staff Device Quality Engineer (Strategic & Hands-on)
Builds
AI-driven non-invasive cardiac test software (Heartflow FFRCT Analysis, RoadMap Analysis, Plaque Analysis) and cloud infrastructure (SaaS)
Domain
Medical Device / Digital Health / AI & Machine Learning
Deliverable
production ML models | product features | infrastructure
Required skills
Global regulatory standards expertise (IEC 62304, ISO 13485, ISO 14971), QMS architecture design, AI/ML validation strategy, risk management (Hazard Analysis, FTA, FMEA), Design History File governance, audit leadership, technical documentation for regulatory submissions, team mentorship
Preferred skills
Master's degree in technical/quality discipline, ASQ CQE, CSQE, or Black Belt certification
Technologies
Cloud Infrastructure (SaaS), AI/ML frameworks, QMS tools
Responsibilities
Lead application and interpretation of global regulatory standards (IEC, ISO, AAMI) for daily development; Architect and own validation frameworks for AI/ML, Cloud, and Cybersecurity within QMS; Define and champion 'Compliance at Speed' frameworks across engineering teams; Drive continuous improvement of the QMS and partner on product strategy; Lead and govern software architecture reviews for safety-by-design and privacy-by-design; Own and govern comprehensive risk management activities (Hazard Analysis, FTA, FMEA); Define and own organization-wide Software Verification and Validation (V&V) strategy; Define standards for and govern the Design History File (DHF) from concept to commercialization; Lead and coordinate the organization during internal and external audits (FDA, Notified Body, MDSAP); Author, review, and approve technical files for global regulatory submissions (FDA 510k/De Novo, PMDA, EU-MDR); Provide technical coaching and quality training to R&D and Product teams
Seniority
Staff, strategic oversight with hands-on leadership