Staff Human Factor Engineer
Not Disclosed•Full-TimeOn-site
location_onFirst Drive West, San Francisco, California, 94129, United States
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. Our 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, assess coronary blood flow, and characterize and quantify coronary atherosclerosis. 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. Our solutions are supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan, and Canada, and have 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 from the leading cause of death into a condition that can be managed for life, we want to hear from you.
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
Positions posted for Heartflow are not intended for or open to third-party recruiters or agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals. Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with '@heartflow.com' and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
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Frequently asked questions about Staff Human Factor Engineer at Heartflow
What does a Staff Human Factor Engineer at Heartflow do?expand_more
A Staff Human Factor Engineer at Heartflow is responsible for the following: Establish and drive SaMD human factors and usability strategies in accordance with IEC 62366-1, FDA guidance, and EU MDR expectations; Execute and document usability engineering evaluations including task analyses and human factors studies; Plan, coordinate, and moderate formative and summative usability studies with external vendors; and Perform root cause analysis of use errors and aggregate data for presentations and formal reports.
What are the requirements for this Staff Human Factor Engineer role?expand_more
To qualify for the Staff Human Factor Engineer at Heartflow position, applicants should have: 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); and Strong written and verbal communication skills; track record of authoring HFE reports that withstand regulatory review.
Where is the Staff Human Factor Engineer role at Heartflow located?expand_more
Staff Human Factor Engineer at Heartflow is based in First Drive West, San Francisco, California, 94129, United States. This is a on-site role.