Senior Human Factors Engineer
Our client a high potential start up are currently seeking a Senior Human Factors Engineer to join their team. Reporting to R&D Director Senior Human Factors Engineer will be responsible developing user requirement for device
Role/Responsibilities:
1. Lead the human factors process of the for a novel medical device, in compliance to internal procedures including EU and FDA requirements from design phase up through to production.
2. Lead coordination of user studies
3. Developing and delivering project plans to performance, time, and cost targets.
4. Lead the development of design and risk management documentation for human factors, including Market requirements, Design Specifications, Design Verification and Validation protocols and reports.
5. Act as voice of the customer in product and user experience design for a novel medical device.
6. Provide input into design reviews and identify potential design risks and develop appropriate risk mitigation plans.
7. Support preparation of compliance package for product evaluation / certification
8. Lead preparation of demos for user studies, company presentations, etc.
9. Lead clinical studies involving the use of the developed products.
10. Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation.
11. Ensure full traceability of Design Development and control of changes.
For further information please contact James Cassidy or call in confidence 086 0204322