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 james.cassidy@lifescience.ie or call in confidence at 086 0204322.
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