Title: Human Factor/Usability Engineer
Summary
Currently there is an immediate opening for a Human Factor/Usability Professional at a leading biotechnology company that focuses on innovative products across several therapeutic areas. The right candidate will have a background within the medical device industry.
Summary:
The responsibilities include planning and supporting HF projects. To assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Life Cycle Management phases.
Location: Greater Los Angeles, CA.
Qualifications and Skills:
B.A or M.S
HFE/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support.
Experience with Human Factor methods - (ethnographic research, contextual inquiries, use scenarios, etc.)
Combination product experience
Knowledge of FDA's Human Factors Guidance, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601
Experience in Task Analysis, User Related Risk Analysis, Direct Involvement in FDA Submissions
