Senior Human Factors Engineer
Core
Lead Human Factors and Usability Engineering activities across the product lifecycle to ensure medical devices are safe and effective, minimizing use errors and advising on design validation.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Safe and effective medical device user interfaces, packaging, labeling, and instructions for use
Domain
Medical Devices / Human Factors Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human Factors Engineering, Usability Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, Industrial Engineering, Cognitive Engineering, task analysis, risk assessment, Design Validation, simulated use studies, user research, contextual inquiry, heuristic analysis, regulatory compliance (FDA, ISO, IEC, 21 CFR 820.30, ISO 14971)
Preferred skills
Formative and summative usability studies, protocol and report generation, user research activities, use-related risk assessments, aseptic presentation evaluations
Technologies
FDA guidance, AAMI HE 75, ISO 62366, IEC 60601-1-6, ISO 11607-1, 21 CFR 820.30, ISO 14971
Responsibilities
Lead Human Factors activities from concept through post-market surveillance; execute usability studies with end users; conduct user research and distill insights; create and maintain usability engineering documentation; identify and assess potential use errors and hazards; lead Design Validation activity planning and execution; create and update internal procedures; lead training workshops and mentor engineers
Seniority
Senior, hands-on IC with mentorship responsibilities
