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.
- 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.
Required Qualifications- Education: BS/MS in Human Factors Engineering, Human-Computer Interaction, Biomedical Engineering, Cognitive/Experimental Psychology, or related discipline.
- Experience: 7+ years of human factors engineering experience in medical devices, combination products, or regulated healthcare software (SaMD).
- Regulatory Fluency: Deep working knowledge of IEC 62366-1, FDA Human Factors guidance (2016), ISO 14971, and EU MDR usability expectations.
- Validation Track Record: Demonstrated ownership of summative human factors studies supporting successful regulatory submissions (e.g., 510(k), De Novo, PMA, or MDR technical documentation).
- Methods: Proficiency in task analysis, use-FMEA/URRA, contextual inquiry, and moderated usability testing (in-person and remote).
- Communication: Strong written and verbal communication skills; track record of authoring HFE reports that withstand regulatory review.
- Travel: Available for up to 25% of travel, including both domestic and international trips (must be cleared for international travel).
How You Stand Out- Clinical Domain: Experience with cardiovascular imaging, CT/MRI workflows, interventional cardiology, or AI/ML-enabled clinical decision support.
- Simulation Experience: Experience running simulated-use studies in high-fidelity clinical or cath-lab simulation environments.
- Adjacent Standards: Familiarity with IEC 60601-1-6, IEC 62304, ISO 13485, and 21 CFR 820 design controls.
- Certification: CHFP or CPE certification.
A reasonable estimate of the base salary compensation range is $190,000 to $250,000, bonus, and equity. #LI-IB1
