Senior Human Factors Engineer

Senior Human Factors Engineer

Reference: JCAO0112
Location: Dublin
Qualification: Degree
Experience: 4-5 Years
Job Type: Permanent
Salary: Not Disclosed Our client, a high potential start-up, is currently seeking a Senior Human Factors Engineer to join their team.
Reporting to the R&D Director, the Senior Human Factors Engineer will be responsible for developing user requirements for devices.
Role/Responsibilities:Lead the human factors process for a novel medical device, in compliance with internal procedures including EU and FDA requirements from design phase up through to production.Lead coordination of user studies.Develop and deliver 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 the 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 packages 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.For further information, please contact James Cassidy at ****** or call in confidence at 086 0204322.

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