Senior Human Factors Engineer
Core
Lead usability engineering and human factors validation for complex, software-controlled electro-mechanical medical devices to ensure safety and ease of use.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Usable, safe medical devices (e.g., robotic-assisted surgery systems) for clinical use
Domain
Medical Devices / Healthcare Technology
Required skills
Usability engineering, Human factors analysis, Risk assessment, Usability testing design & execution, Regulatory documentation, User research, Validation strategy, Technical writing, Cross-functional collaboration, Mentorship
Preferred skills
Medical device industry experience, Regulated industry experience, MS in relevant field
Technologies
IEC 62366, AAMI HE75, FDA Human Factors guidelines
Responsibilities
Conduct user research and usability testing; Create and update usability risk analyses; Design and execute FDA-mandated validation tests; Write protocols and reports for regulatory submission; Mentor junior engineers; Coordinate human factors efforts across multi-subsystem projects; Advise on regulatory compliance and process improvements
Seniority
Senior, hands-on IC with mentorship responsibilities