Usability Engineering Lead
Core
Lead usability engineering and human factors activities for medical device product development, ensuring safety and usability from concept through verification.
Role type
Senior Usability Engineering Lead (Human Factors)
Builds
Safe, user-friendly medical devices and a scalable usability engineering practice
Domain
Regulated medical devices (hardware/software combinations and SaMD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IEC 62366-1 implementation, FDA human factors guidance, use-related risk analysis, design validation, formative and summative evaluation planning, ISO 13485 and EU MDR compliance, hardware-software integration
Preferred skills
Early-stage startup scaling, building new practices/domains, ISO 14971 risk management
Technologies
IEC 62366-1, FDA guidance, ISO 13485, EU MDR, ISO 14971
Responsibilities
Lead usability engineering activities from early concept to final verification; grow the usability domain capability and best practices; improve integration of usability engineering with product development; collaborate with cross-functional teams for early design feedback; plan and execute usability evaluations; oversee validation of UI requirements and verification of risk controls
Seniority
Senior, hands-on IC with domain leadership
