About the job
About HeartFlow
HeartFlow, Inc. develops medical technology to improve the diagnosis and management of coronary artery disease. The company’s flagship HeartFlow FFRCT Analysis uses advanced AI to create non-invasive, color-coded 3D models of coronary arteries, helping clinicians understand how blockages impact blood flow. HeartFlow’s integrated heart care platform supports clinicians in identifying stenoses (RoadMap™ Analysis), assessing coronary blood flow (FFRCT Analysis), and characterizing atherosclerosis (Plaque Analysis).
HeartFlow is publicly traded (HTFL) and recognized internationally for healthcare innovation. Its solutions are approved in the US, UK, Europe, Japan, and Canada, and have supported care for over 500,000 patients worldwide.
Role Overview: Senior Manager of Device Quality Engineering
The Senior Manager of Device Quality Engineering leads the global strategy for software quality and design excellence at HeartFlow. This role builds and manages a high-performing team, connecting fast-moving Agile development with the rigorous demands of medical device regulations. The team’s work covers digital health solutions, including Software as a Medical Device (SaMD) and AI/ML technologies, with a focus on safety, security, compliance, and scalability.
Main Responsibilities
- Direct the end-to-end design control process within the Software Development Lifecycle (SDLC).
- Develop and implement a roadmap for compliance, security-by-design, and readiness for global regulatory requirements.
- Mentor and develop future leaders in quality engineering.
- Bridge Agile software development practices with medical device regulatory standards.
Location
San Francisco Bay Area, California, United States
