A global medical device company are looking for a Human Factors Engineer to join their Research and Development team on a contract basis. You will work with relevant R&D engineers to conduct field case research and case study observation with the ability to apply findings into human interface requirements and for the purpose of concept selection/refinement, use-related risk identification and formal usability validation with intended users. Your role will support on 2 their latest projects.
Essential skills:
- Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance
- Experience in writing formative and summative usability test protocols and reports and designing instructions for use (IFU) documents
o Knowledge and experience with user / use environment research, scenario development and documentation
- Skilled in conducting usability evaluations, including facilitation and observation & supports risk management.
Desirable skills:
- Experience in compiling the usability engineering file (UEF) for regulatory submissions therefore developing use specifications, use errors, UOUP, Task analysis, uFMEA
- Knowledge of medical device usability regulatory standards and requirements.
- Ability to lead all Human Factors/Usability activities on development project and able to progress work independently with minimal supervision
The start date is for ASAP/5th August. The initial contract length is for 6-12 months, with options to extend after. The role is based in Limerick but will be remote based. The rate is €52 per hour, depending on experience, if you have any expenses please let me know and I can factor that into the rate for you.
If you are interested in the role please send me your latest CV and I will call you to discuss the further details.
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