Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR CT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFR CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).

Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide. As the Senior Manager, Device Quality Engineering , you will lead the global strategy for software quality and design excellence.

You will be responsible for building and managing a high-performing team that bridges the gap between rapid Agile development and rigorous medical device regulations. Your leadership ensures that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, compliant, and scalable. Your core responsibility will be the strategic oversight of the end-to-end design control process within the Software Development Lifecycle (SDLC).

You will define the roadmap for compliance, security-by-design, and global regulatory readiness while mentoring the next generation of quality engineering leaders.

Key Responsibilities

Strategic Leadership Team Management Departmental Authority: Serve as the primary leader and organizational authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45. QMS Roadmap: Drive the evolution of the Quality Management System (QMS), establishing the vision for validation frameworks involving AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1). People Leadership: Recruit, mentor, and develop a team of quality engineers, fostering a culture of "Compliance at Speed" through Agile best practices.

Release Accountability: Ensure predictable, complete, and high-quality releases by managing resource allocation and departmental throughput. Design Quality Risk Governance Architectural Oversight: Direct the review of software architecture to ensure the implementation of safety, security-by-design, and privacy-by-design across all product lines. Risk Management Governance: Oversee comprehensive risk management activities, ensuring consistency across Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs for software-driven failure modes.

V V Strategy: Act as the final authority for Software Verification and Validation (V V) strategies; ensure protocols and reports meet the highest standards of robust product performance. Execution Compliance DHF Lifecycle Management: Ensure organizational compliance from concept to commercialization by governing the Design History File (DHF) and design transfer processes. , FDA, Notified Body, MDSAP).

Cross-Functional Collaboration Regulatory Partnership: Partner with Regulatory Affairs leadership to strategize and approve technical documentation for global submissions, including FDA, PMDA, and EU-MDR. Executive Influence: Provide technical guidance and status updates to R D, Product, and Program Management executives.