Human Factors EngineerWe are seeking a Human Factors Engineer to support the development of innovative medical devices and combination products by ensuring user needs, safety, and usability are integrated throughout the product development lifecycle. This individual will partner closely with cross-functional teams including engineering, marketing, medical, and regulatory affairs to plan, execute, and document human factors activities that support product design decisions and regulatory submissions. The role will focus on conducting user research, leading usability studies, performing use-related risk assessments, and ensuring compliance with FDA guidance and applicable human factors standards.Key responsibilities include:Provide expert Human Factors Engineering guidance based on usability activity results and Human Factors Engineering principlesProvide use-related input into the creation of product and system requirements based on user needs and Human Factors Engineering expertisePartner with marketing, medical, engineering and others to plan and conduct Human Factors Engineering activities, including but not limited to:Conceptualizing, organizing, and leading the conduct of user research studies (e.g., contextual inquires, diary studies, observational studies)Leading the development of protocols, study designs, and execution of formative and summative (HF Validation) usability studiesConducting heuristic evaluations and expert reviewsConducting use-related risk analysisLeading the reporting and disposition of Human Factors Engineering evaluation findingsDrafting technical documents (e.g., use-specification) for usability files within the DHF and as guidance for late-stage developmentAuthoring Human Factors Engineering / Usability Engineering reports for regulatory submissionServe as an opinion leader, internally and externally, including seeking opportunities to publish and speak publicly about Human Factors EngineeringConducting Human Factors Engineering educational workshops and seminars to multi-functional audiencesAssisting in internal Human Factors Engineering staff training and process improvement activitiesAssisting in maintaining procedures and tools on best practices related to Human Factors EngineeringIt is also important that individuals in this role ensure the following:User capabilities and limitations and associated use-related risks are appropriately addressed in planning, requirements development, and design & engineeringUser performance characteristics and their associated benefits and risks assist in deciding among design alternativesCompliance to relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and FDA guidance is adequately addressed in Human Factors Engineering processes and deliverablesQualificationsEducation/Experience5-8 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 necessary
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