We're seeking an experienced Human Factors Engineer IV to support the research, design, and validation of innovative medical devices. This role is ideal for professionals with expertise in usability engineering, user-centered design, risk analysis, and FDA human factors validation within regulated healthcare environments.Key ResponsibilitiesConduct user research through interviews, simulations, observations, and task analyses to understand user needs and use environments.Perform task analyses, identify use-related hazards, and support usability risk assessments throughout product development.Plan, execute, and report formative usability studies and FDA-required human factors validation testing.Partner with Product Development teams to influence user interface design and improve product usability.Analyze customer complaints and post-market feedback to identify usability-related issues.Develop and maintain user interface requirements, usability risk analyses, and traceability between hazards, mitigations, and validation activities.Present usability findings and recommendations to Engineering, Product Management, Clinical, Quality, and Regulatory teams.Stay current with medical device human factors standards and regulatory guidance.QualificationsBachelor's or Master's degree in Human Factors Engineering, Human-Computer Interaction (HCI), Cognitive Psychology, Human-Centered Design, Computer Science, or a related field.5+ years of Human Factors Engineering experience in industry.Strong understanding of user-centered design and usability engineering principles.Experience planning and executing usability studies and validation testing.Knowledge of: IEC 62366; AAMI HE75; FDA Guidance: Applying Human Factors and Usability Engineering to Medical DevicesExcellent analytical, communication, presentation, and collaboration skills.Ability to work effectively with Engineering, Clinical, Regulatory, Quality, and Product Management teams.Willingness to travel domestically up to 25%.Experience in medical devices or another regulated industry is strongly preferred.
3 days ago