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 andsummative 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/August. The initial contract length is for 12 months, with options to extend after. The role is based in Limerick and will require 1 days onsite per week, the rest of the time you can work remotely. The rate is €45-55 per hour, depending on experience, if you have any expenses please let me know and I can factor that into the rate for you.