Heartflow
medical technology
StaffHumanFactorEngineer
Neural analysis suggests this role is
optimal for Staff candidates.
“Staff Human Factor Engineer at Heartflow. Skills: Human Factors Strategy, Usability Engineering, SaMD Human Factors, Usability Studies. Lead usability engineering across our AI-driven medical device portfolio. Drive the human factors strategy and lifecycle from use-related risk analysis through formative evaluation and summative validation”
What You'll Achieve.
Transform coronary artery disease (CAD) from the leading cause of death into a condition that can be managed for life
Industry & Context.
Root cause analysis of use errors
Available for up to 25% of travel, including both domestic and international trips, Must be cleared for international travel
What They're Looking For.
Must Have
Experience with cardiovascular imaging, CT/MRI workflows, interventional cardiology, or AI/ML-enabled clinical decision support, Experience running simulated-use studies in high-fidelity clinical or cath-lab simulation environments, Familiarity with IEC 60601-1-6, IEC 62304, ISO 13485, and 21 CFR 820 design controls
Nice to Have
CHFP or CPE certification
What You'll Do.
Lead usability engineering across our AI-driven medical device portfolio
Drive the human factors strategy and lifecycle from use-related risk analysis through formative evaluation and summative validation
Establish and drive SaMD human factors and usability strategies in accordance with IEC 62366-1
FDA Human Factors guidance
and EU MDR expectations
Execute and document usability engineering evaluations
including task analyses and human factors studies
Author formative and summative usability study protocols
and moderate formative and summative usability studies
Perform root cause analysis of use errors and aggregate data for presentations and formal reports
Partner with external vendors as required to execute human factors evaluations (recruiting
track record of authoring HFE reports that withstand regulatory review)
How You'll Work.
Team & Collaboration
Partnering across Product, Engineering, Clinical, Regulatory, and Quality
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. We are seeking an experienced Staff Human Factors Engineer to lead usability engineering across our AI-driven medical device portfolio. Reporting to the Sr. Director of Systems Engineering, you will drive the human factors strategy and lifecycle from use-related risk analysis through formative evaluation and summative validation. If you are energized by running rigorous usability studies, translating clinical workflow insights into design decisions, and partnering across Product, Engineering, Clinical, Regulatory, and Quality to transform coronary artery disease (CAD) from the leading cause of death into a condition that can be managed for life. Job Description Establish and drive SaMD human factors and usability strategies in accordance with IEC 62366-1, FDA Human Factors guidance, and EU MDR expectations. Execut
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