Job Description - Principal Human Factors Engineer
Perform activities in partnership with functional engineering groups, quality, regulatory, marketing, clinical, and R&D to ensure that those products are safe and meet the needs of the customers. Provide HFE input based on field user research and usability evaluations to the project teams to enable design of user interfaces. Perform task and use error risk analysis, heuristic evaluations, cognitive walk throughs, and formative and summative testing. Apply knowledge of device users, tasks, and use environments to the design and development of new products and product changes. Deliver verbal, written and visual communications, with an emphasis on problem framing, visual storytelling and strong information design to internal and external key stakeholders. Prepare documentation to support development activities, usability engineering files, including usability engineering plans, formative and summative study protocols/moderator guide/reports, task and use error analysis, and technical reports. Bachelor's degree in a technical discipline with experience or degree related to Human Factors 7+ years of Human Factors or related work experience (primarily in medical device or related field) or 5+ years with related Master's degree Experience planning, coordinating, conducting, analyzing, and reporting on Formative and Summative usability studies Experience with various Human Factors methodologies such as ethnographic research, contextual inquiry, cognitive walk through, expert analysis, task and use error analysis, simulated use usability studies, and summative testing Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources. Ability to be collaborative and flexible in approach to solving user interface related challenges Ability to clearly communicate how study results can be implemented into design, including analyzing and synthesizing large quantities of information into usable content for project teams and the business BS, MS or Minor in Engineering, or relevant experience in a technical discipline Experience applying human factors standards and guidance to new product development, preferably within the medical device industry Experience developing Class II or Class III medical devices Experience with medical device quality systems
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