Conducts usability activities across all development phases in collaboration with multidisciplinary teams including UI/UX, product design, clinical, R D, and system engineering. Define the usability engineering approach for projects, including planning activities, resources, and usability integration throughout development. Conduct and lead user research, usability testing (formative and summative), task analysis, and risk assessments (usability FMEA), and generate documentation for regulatory submissions (FDA, EU-MDR, CMDE). Identify, analyze, and document usability risks and potential use errors through comprehensive usability risk analyses. Plan, conduct, and report usability studies in compliance with privacy, usability, and legal requirements, including NDAs, site agreements, and informed consent. Analyze post market data and create Human Factors Engineering and usability documentation to demonstrate product safety, effectiveness, and regulatory compliance. Collaborate with cross-functional teams including engineering, clinical, marketing, quality, regulatory, and service to deliver human-centered solutions that meet global medical device standards. Work on usability documentation and report outs related to usability studies like expert review, formative evaluation and summative usability evaluations. Create usability testing protocols, select user profiles, create usability test plans and prioritize feedback and findings into safety, critical and other categories. Stay ahead of usability regulations (IEC 62366, ISO 14971, FDA guidance) and advise teams on compliant, user-focused product development.
Skills:
Bachelor's or Master's degree in Industrial Design, Product Design, Cognitive Psychology, or a related field with a focus on Human Factors or Human-Computer Interaction (HCI). 5+ years of experience in usability, human factors, or user-centered design ideally in medical devices or other high-regulation industries (aviation, automotive, military). Strong research and communication skills, with the ability to translate user needs into actionable design input and strategic direction. Familiar with medical device usability and risk management standards (e.g., IEC 62366, FDA guidance, ISO 14971, EU-MDR).
