Human Factors Engineer
Kaleidoscope Animations - New York City, NY
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Qualifications:2-5 years of experience with medical devices and FDA submissionsexperience in early stage human factors research/activities in innovation/early phase projectsplanning and executing usability studies, and preparing FDA submission documentscombination product or medical mobile app experience is a bonus but not necessaryResponsibilities: Provide expert Human Factors Engineering guidance based on usability activity results and Human Factors Engineering principles Provide use-related input into the creation of product and system requirements based on user needs and Human Factors Engineering expertise Partner with marketing, medical, engineering and others to plan and conduct Human Factors Engineering activities, including but not limited to: Conceptualizing, organize, and lead the conduct of user research studies (e.g., contextual inquires, dairy studies, observational studies) Lead the development of protocols, study designs, and execution of formative and summative (HF Validation) usability studies Conduct heuristic evaluations and expert reviews Conduct use-related risk analysis Lead the reporting and disposition of Human Factors Engineering evaluation findings Draft technical documents (e.g., use-specification) for usability files within the DHF and as guidance for late-stage development Author Human Factors Engineering / Usability Engineering reports for regulatory submission Serve as an opinion leader, internally and externally, including seeking opportunities to publish and speak publicly about Human Factors Engineering Conducts Human Factors Engineering educational workshops and seminars to multi-functional audiences within Lilly Assist in internal Human Factors Engineering staff training and process improvement activities
Created: 2024-09-07