The Senior Human Factors Engineer represents the Human Factors Engineering discipline on multiple programs, operating with moderate supervision while independently managing assigned Human Factors scope. Has the ability to take an increasingly independent role in support of larger programs, serving as a key stakeholder on cross-functional R&D teams. Demonstrates strength in select Human Factors Engineering skills. Leads the development of Human Factors lifecycle documentation such as Use Specifications, Use-Related Risk Analysis, Formative Protocols/Reports, Summative Protocols/Reports, and Usability Engineering Files with increasingly limited supervision. Plans and conducts customer and competitive research to: identify, prioritize, and develop new projects; create detailed design improvement plans/concepts; and lead internal/external design and development resources. Applies Human-centered Design and Human Factors Engineering principles, collaborating closely with UI/UX partners to support the evaluation and solution of complex product design problems. Consistently monitors professional landscape for usability process improvement opportunities. Exercises independent judgment in planning, organizing, and performing work; monitors and reports status to manager. Represents the Human Factors Engineering function and perspective on core teams – strongly advocating for user and customer centricity through optimal design. Creates and revises accurate documentation related to the Human Factors & Usability Engineering Process for multiple projects with a higher level of independence, including but not limited to: Usability Engineering Plans, Use Specifications, Use-related risk analyses, Usability Study Protocols & Reports, and Usability Engineering Files. Interfaces and builds rapport with a complex network of users including expert customer HCPs, translating feedback from these users into actionable design improvements for the project team. Defines, leads, and conducts usability testing from early product prototyping to product validation studies. Creates detailed design improvement concepts and effectively communicates the value of those concepts to the project teams. Works across product lines and internal departments to create and manage usability evaluation and/or improvement plans. Investigates and defines usability requirements for new product/feature development and facilitates the translation into new projects through usability testing. Identifies and analyzes use errors and issues for medical devices and translates these into specific system risk mitigations. Simulates or tests aspects of new projects to evaluate prototypes and optimizes the user experience. Applies Human Factors, User Experience, User Research, and Human-centered Design principles to determine optimal Human Factors strategies, optimal user interface designs, optimal study designs, and optimal research goals for projects. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Keeps updated on and ensures documents adhere to current Regulatory Guidelines on medical device Human Factors, including: FDA Applying Human Factors and Usability Engineering to Medical Devices, NMPA Guidelines for Usability Engineering of Medical Devices, IEC 62366, and ANSI/AAMI HE75.
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Job Type
Full-time
Career Level
Senior