Beschreibung
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.