Expert Global Human Factors Engineering
Core
Lead human factors engineering for hemodialysis medical devices (active and non-active, Class II/II) to ensure usability and safety across global markets.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Hemodialysis systems, RO systems, and related medical IT interfaces
Domain
Medical Devices / Renal Care / Dialysis
Required skills
Human factors engineering, Usability engineering, Task analysis, UI design requirements, Risk analysis (uFMEA), Formative and summative evaluation planning, Regulatory documentation (CE, NMPA, FDA), Clinical context research, Technical writing
Preferred skills
Renal replacement therapy domain knowledge, Extracorporeal therapy experience, UI/UX prototyping tools (XD, Figma, Axure), Video/audio editing
Technologies
MS Office, Video/Audio editing tools, IEC 62366-1/2, ISO 14971
Responsibilities
Conduct user and use environment research across China, APAC, and globally; Support concept and design with use cases and task analysis; Organize and document formative and summative usability evaluations; Consult on usability engineering documents for regulatory authorities; Maintain usability lab equipment and environment.
Seniority
Senior, hands-on IC