Heartflow
Healthcare
StaffDeviceQualityEngineer
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“Staff Device Quality Engineer at Heartflow. Skills: Software Quality, Design Excellence, Medical Device Regulations, QMS, Risk Management. Serve as the senior technical authority for software quality and design excellence across multiple product lines and platform initiatives. Shape quality engineering practices organization-wide, bridging the gap between rapid Agile development and rigorous medical device regulations. Ensure that software architecture, security, and global regulatory requiremen”
What You'll Achieve.
Ensure that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, and compliant. Drive continuous improvement of the QMS, identifying systemic gaps and leading cross-functional initiatives to address them. Ensure DHF completeness and quality across multiple concurrent programs.
Industry & Context.
system design; risk management; Hazard Analysis; Fault Tree Analysis (FTA)
Ability to work as a self-starter in a fast-paced, adaptive environment. Serve as the quality sign-off authority for regulatory submissions. Contribute to hiring and capability planning.
What They're Looking For.
Must Have
Deep expertise in quality systems strategy, including QMS architecture and CAPA program design for SaMD organizations. Demonstrated ability to influence without authority and drive alignment across engineering, regulatory, and product leadership.
What You'll Do.
Serve as the senior technical authority for software quality and design excellence across multiple product lines and platform initiatives.
Shape quality engineering practices organization-wide, bridging the gap between rapid Agile development and rigorous medical device regulations.
Ensure that software architecture, security, and global regulatory requirements are integrated into every release.
Serve as a key decision-maker and escalation point for quality and compliance matters.
Strategic oversight and hands-on leadership of the end-to-end design control process within Heartflow’s Software Development Lifecycle (SDLC).
How You'll Work.
Team & Collaboration
Highly cross-functional role requiring collaboration with engineering, regulatory, and product leadership. Mentor and develop Senior and mid-level Quality Engineers.
Communication Scope
communication; documentation
Process & Methodology
time management
Full Job Description
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 FFRCT 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 (FFRCT 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 a Staff Device Quality Engineer, you will serve as the senior technical authority for software quality and design excellence across multiple product lines and platform initiatives. In this highly cross-functional, strategic role, you will shape quality engineering practices organization-wide, bridging the gap between rapid Agile development and rigorous medical device regulations, ensuring that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, and compliant. Your core responsibility will be strategic oversight and hands-on leadership of the end-to-end design control process within Heartflow’s Software Development Lifecycle (SDLC). You will ensure that software architecture, security, and global regulatory requirements are integrated into
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