Staff Human Factor Engineer

Heartflow•San Francisco, CA

About The Position

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. 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.

Requirements

BS/MS in Human Factors Engineering, Human-Computer Interaction, Biomedical Engineering, Cognitive/Experimental Psychology, or related discipline.
7+ years of human factors engineering experience in medical devices, combination products, or regulated healthcare software (SaMD).
Deep working knowledge of IEC 62366-1, FDA Human Factors guidance (2016), ISO 14971, and EU MDR usability expectations.
Demonstrated ownership of summative human factors studies supporting successful regulatory submissions (e.g., 510(k), De Novo, PMA, or MDR technical documentation).
Proficiency in task analysis, use-FMEA/URRA, contextual inquiry, and moderated usability testing (in-person and remote).
Strong written and verbal communication skills; track record of authoring HFE reports that withstand regulatory review.
Available for up to 25% of travel, including both domestic and international trips (must be cleared for international travel).

Nice To Haves

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.
CHFP or CPE certification.

Responsibilities

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.
Plan, coordinate, 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, study design, execution, analysis, & reporting)
Author and update usability risk analyses in collaboration with cross-functional stakeholders.
Partner with Quality teams to address potential complaints related to usability on-market products.
Work with design teams to create clinician-centric and compliant designs.
Assist in developing usability engineering processes for Quality system improvements.
Support inquiries, audits, and discussions with regulatory agencies.