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.
* 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
* 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.