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:

• 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.
• Lead coordination of user studies
• Developing and delivering project plans to performance, time, and cost targets.
• Lead the development of design and risk management documentation for human factors, including Market requirements, Design Specifications, Design Verification and Validation protocols and reports.
• Act as voice of the customer in product and user experience design for a novel medical device.
• Provide input into design reviews and identify potential design risks and develop appropriate risk mitigation plans.
• Support preparation of compliance package for product evaluation / certification
• Lead preparation of demos for user studies, company presentations, etc.
• Lead clinical studies involving the use of the developed products.
• Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation.
• Ensure full traceability of Design Development and control of changes.