Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)

Role: Human Factors Engineering Lead - Associate Engineering Fellow responsible for user-centered design of medical devices and combination products. Objectives include developing and executing human factors strategies aligned with regulatory standards, advancing digital and AI-enabled research capabilities, and ensuring product usability and safety. Responsibilities encompass leading user research (including remote and AI-augmented methods), translating user needs into interface requirements, designing and conducting usability studies, applying risk management, developing validation protocols, managing vendors, and preparing regulatory documentation in compliance with IEC/ISO standards. The role involves cross-functional collaboration across engineering, clinical, regulatory, data science, and quality teams, with an emphasis on fostering innovation and standards development. Qualifications: Doctorate with 7+ years, Master's with 13+ years, or Bachelor's with 15+ years in Human Factors, Biomedical, or related engineering fields; experience with medical device design, regulatory guidance, and human factors standards. HighValue: focus on medical device/hybrid product usability, regulatory compliance, Human Factors validation, and risk management; travel up to 20% domestically and internationally; based in Lexington, MA. The position is full-time, exempt, and involves mentoring and vendor management.