About the job
At HeartFlow, we are pioneering medical technology to enhance the diagnosis and management of coronary artery disease, the leading cause of mortality globally. Our flagship innovation, the HeartFlow FFRCT Analysis, utilizes advanced AI to deliver a non-invasive cardiac test that produces a detailed, color-coded 3D representation of a patient's coronary arteries, revealing how blockages affect blood flow to the heart. As the first AI-driven integrated heart care solution within the CCTA pathway, we empower clinicians to identify stenoses (RoadMap™ Analysis), assess coronary blood flow (FFRCT Analysis), and characterize coronary atherosclerosis (Plaque Analysis). Join our expanding team and contribute to the evolution of precision heart care.
HeartFlow is publicly traded (HTFL) and has garnered international acclaim for its contributions to healthcare innovation. Our solutions are endorsed by medical societies globally, approved for use in the US, UK, Europe, Japan, and Canada, and have benefited over 500,000 patients worldwide.
As the Senior Manager of Device Quality Engineering, you will spearhead the global strategy for software quality and design excellence. Your role involves building and leading a high-performing team, bridging rapid Agile development with stringent medical device regulations. Your leadership will ensure our digital health solutions—encompassing Software as a Medical Device (SaMD) and AI/ML technologies—are safe, secure, compliant, and scalable.
Your primary responsibility will be to strategically oversee the end-to-end design control process within the Software Development Lifecycle (SDLC). You will establish a roadmap for compliance, security-by-design, and global regulatory readiness while mentoring the next generation of quality engineering leaders.

