Human Factors Engineer (Onsite Resources)

Insights & Human Factors Boston, Massachusetts

Qualifications:

  • 2-5 years of experience with medical devices and FDA submissions
  • experience in early stage human factors research/activities in innovation/early phase projects
  • planning and executing usability studies, and preparing FDA submission documents
  • combination product  or medical mobile app experience is a bonus but not necessary
Responsibilities:
  • 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