- This assignment is for a specialist in Human Factors Engineering (HFE) that will contribute to the development of devices and/or systems intended to provide medical therapy for Cardiac Rhythm Management (CRM) division.
- Thus, the usability of these products is regulated by the FDA and IEC standards to ensure the design is safe and the probability of use error that could lead to patient harm have been effectively mitigated.
This assignment assumes the specialist is familiar with these procedures.
- The specialist will be expected to perform the following tasks:
- Produce documentation, reports and analysis that adhere to FDA Guidelines for usability, as well as IEC Standards 62366 (2015) and 60601-1-6 (2015).
- These documents will also adhere to CRM Department Work Instructions (DWI) 60022669/D Human Factors Engineering Instructions.
- Conduct detailed complaint analysis on current products in relation to usability
- Create and execute formative usability studies.
- Create and execute summative usability studies.
- Ensure HFE deliverables align with CRM Risk Management process.
- Educ is minimum of Masters Mastery of human factors within medical device is most important 3 to 5 years of experience.
Human Factors Engineering, HFE, Human Factors, usability , Ergonomics, IEC , FDA , 62366, 60601-1-6, Medical Device