Expert Global Human Factors Engineering
Core
Lead human factors engineering for hemodialysis medical devices, ensuring usability and safety for clinical teams and patients globally.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Hemodialysis systems, renal replacement therapy products, and associated medical IT interfaces
Domain
Healthcare / Medical Devices / Renal Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human factors engineering, usability engineering, task analysis, risk analysis (uFMEA), formative and summative evaluation planning, regulatory documentation (IEC 62366-1, ISO 14971, FDA/NMPA), clinical context research, UI design requirements definition
Preferred skills
Renal replacement therapy product knowledge, extracorporeal therapy experience, usability lab management, video/audio editing for assessments, UI/UX prototyping tools
Technologies
IEC 62366-1, ISO 14971, FDA HFE guidance, NMPA UE guidance, MS Office, video/audio editing software
Responsibilities
Conduct user and use environment research across China, APAC, and global regions; Support concept and design with use cases and task analysis; Organize and document formative and summative usability evaluations; Prepare usability engineering documents for regulatory authorities; Maintain usability lab equipment and environment
Seniority
Senior, hands-on IC