Human Factors Engineer | Consultant
Core
Conduct usability engineering studies and risk analysis for medical devices and combination products to ensure user safety and regulatory compliance.
Role type
Junior Human Factors Engineer (Consulting)
Builds
Usability engineering files, study protocols, risk analysis documents, and validation reports for medical technology clients.
Domain
Medical devices and healthcare technology
Required skills
Usability engineering processes, Human factors standards (IEC 62366, FDA, ISO 14971), Task analysis, Use-FMEA, Formative and validation study planning, Data analysis and reporting, Risk management, Project management
Preferred skills
Medical device development lifecycle knowledge, Risk management processes
Technologies
IEC 62366, FDA guidance, ISO 14971, Use-FMEA
Responsibilities
Collaborate on usability engineering efforts for medical devices, Plan and conduct usability studies (moderating, analyzing, reporting), Create usability documentation (use specs, UI specs, risk docs), Support HF validation testing, Assist with risk management tasks, Present study results to clients and teams.
Seniority
Junior, hands-on IC