Human Factors Specialist

Sector:
Pharmaceutical
Location:
Switzerland
Sub-location:
Any
Currency:
£
Job Type:
Any
Salary Description:
Negotiable
Posted:
07/05/2019
Ref No:
123504

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.

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