Human Factors Engineer
Core
Lead Human Factors and Usability Engineering for physical medical devices and connected health software to ensure regulatory compliance and safe patient use.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Physical medical devices and connected health software platforms
Domain
Regulated medical devices and digital health
Required skills
Human Factors Engineering, Usability Engineering, IEC 62366-1, FDA Human Factors guidance, ISO 14971, use-related risk analysis (URRA), formative and summative usability studies, connected product development, SaMD
Preferred skills
FDA submission support (De Novo/510k), home-use device experience, Instructions for Use (IFU) creation, accessibility standards, behavioral science
Technologies
IEC 62366-1, FDA guidance, ISO 14971, URRA
Responsibilities
Lead Human Factors and Usability Engineering activities for medical device and digital health programs, Plan and execute usability engineering activities in accordance with IEC 62366-1, FDA Human Factors guidance, ISO 14971, MDR, and FDA requirements, Develop and maintain Human Factors deliverables including use specifications, task analyses, use-related risk analyses (URRA), formative and summative study plans, and Human Factors reports, Define Human Factors design inputs for both physical devices and software solutions, Work with multidisciplinary teams to ensure Human Factors findings are translated into product requirements and design decisions, Support regulatory submissions in the US and international markets, Develop and improve internal Human Factors Engineering processes, procedures, templates, and best practices within our Quality Management System, Contribute to capability development across the organization through mentoring, coaching, and knowledge sharing, Participate in client workshops, design reviews, and product strategy discussions
Seniority
Senior, hands-on IC
