Senior Device Quality Engineer
Core
Lead end-to-end design control and quality assurance for AI/ML-enabled Software as a Medical Device (SaMD) within the Software Development Lifecycle (SDLC), ensuring compliance with global medical device regulations.
Role type
Senior Device Quality Engineer (Software & AI/ML focus)
Builds
AI-driven non-invasive cardiac analysis software (Heartflow FFRCT Analysis, RoadMap Analysis, Plaque Analysis)
Domain
Medical Device / Digital Health / Cardiovascular AI
Deliverable
production ML models | product features
Required skills
Software Engineering, Computer Science, Biomedical Engineering, IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45, ISO 81001-5-1, Hazard Analysis, Fault Tree Analysis (FTA), Software FMEA, Software Verification and Validation (V&V), Design History File (DHF) management, FDA 510k/De Novo, EU-MDR, PMDA
Preferred skills
ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Green Belt
Technologies
Cloud Infrastructure (SaaS), AI/ML frameworks
Responsibilities
Apply global regulatory standards to daily development activities; Implement validation frameworks for AI/ML, Cloud Infrastructure, and Cybersecurity; Partner with engineering teams to execute Agile sprints meeting regulatory rigor; Participate in software architecture reviews for safety-by-design and privacy-by-design; Facilitate and document comprehensive risk management activities including Hazard Analysis, FTA, and Software FMEAs; Act as lead for Software Verification and Validation (V&V) developing and executing test strategies; Manage the Design History File (DHF) from concept to commercialization; Support the organization during internal and external audits as a subject matter expert; Author technical files for global submissions including FDA, PMDA, and EU-MDR; Provide technical coaching and quality training to R&D and Product teams.
Seniority
Senior, hands-on IC
