Human Factors Specialist

Bern  ‐ Onsite
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Description

We have a very exciting new position for a leading Medical Device company, world leaders in the Orthopaedics industry. They are looking for a Human Factors Engineer who will work in the R&D department to develop next generation of innovative medical devices.

Responsibilities:
  • Support front-end ethnographic activities, including observational research and in-context interviews, and consolidate observations into meaningful insights
  • Plan and coordinate usability studies at various stages of product development from early prototypes through formal human factors validation/summative usability testing.
  • You will be involved in a range of activities such as writing and executing test protocols, moderating studies, designing study models, recruiting participants, and preparing other study documentation (e.g., informed consent forms, recruitment screeners, moderator's guides)
  • Analyze test data, perform thoughtful and thorough root cause analysis, and write test reports
  • Document known use-related problems (e.g. predicate devices) and author task analyses and use-related risk analyses (AMFEA/UFMEA) in collaboration with project team
  • Make user interface design recommendations based on user feedback, empirical data, literature searches, and industry best practices.
  • Ensure compliance to internal usability procedure and latest Human Factors regulations.
  • Work with cross functional teams to develop and refine usability processes
  • Prepare and review documentation for submission to regulatory agencies and notified bodies. Answer questions and provide rationales as needed.
  • Represent the Human Factors function on multiple project teams and provide schedules and status to project managers.
  • Up to 20% travel required


Requirements:
  • Bachelor's or Master's degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or related field is preferred
  • Minimum 5 years of applied experience in Human Factors or Usability Engineering;
  • Medical Device experience is strongly preferred.
  • Demonstrated experience in the planning and conduct of various user research activities, including ethnography, formative usability tests, and HF validation (summative usability) tests
  • Strong knowledge of human factors principles; working knowledge of task and risk analysis methods, human perception, and cognition; basic knowledge of anthropometrics, biomechanics and physiology
  • Experience consolidating user feedback into concise, meaningful design insights and actionable recommendations. Experience performing root cause analysis for use-related problems is preferred
  • Familiarity with FDA, ISO, IEC, AAMI, and other relevant usability standards and guidances for medical devices is highly preferred
    Kontakt:


Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start date
05/2019
Duration
14/05/2020
From
Michael Bailey Associates
Published at
08.05.2019
Project ID:
1767078
Contract type
Freelance
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