Heartflow is seeking a Senior Device Quality Engineer to lead software quality and design excellence for its innovative AI-driven cardiac solutions. The ideal candidate will have experience in quality engineering within the medical device sector, focusing on compliance with global regulatory standards
Job Summary
Serve as a key technical lead for software quality and design excellence, bridging Agile development and medical device regulations.
Manage the end-to-end design control process within the Software Development Lifecycle (SDLC), ensuring integration of software architecture, security, and global regulatory requirements.
Partner with engineering teams to execute 'Compliance at Speed', ensuring Agile sprints meet regulatory rigor and result in high-quality, predictable releases.
Matching Summary
Match Score: 85
Heartflow is seeking a Senior Device Quality Engineer to lead software quality and design excellence for its innovative AI-driven cardiac solutions. The ideal candidate will have experience in quality engineering within the medical device sector, focusing on compliance with global regulatory standards.
Salary
Base: $160,000 - $180,000; Bonus/Equity: bonus; Benefits: Not specified
Skills & Requirements
Must-have
Software as a Medical Device (SaMD)
AI/ML-enabled technologies
IEC 62304, IEC 82304, ISO 14971
Agile development integration
Design History File (DHF) management
Software Verification and Validation (V&V)
Nice-to-have
Compliance at Speed
Safety-by-design principles
Privacy-by-design principles
Culture of compliance
Key Requirements
5–8 years of experience in quality engineering
Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or related technical field