Senior Human Factors Engineer Role Summary
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We are seeking an experienced Senior Human Factors Engineer to take on a pivotal role in medical device development. This is a high-profile opportunity for a skilled professional to contribute to the creation of novel medical devices.
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Key Responsibilities:
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* Lead human factors engineering processes for medical device design and development, ensuring compliance with EU and FDA regulations.
* Coordinate user studies to inform design decisions and improve user experience.
* Develop and deliver project plans to meet performance, time, and cost targets.
* Create design and risk management documentation for human factors, including market requirements, design specifications, verification, and validation protocols.
* Serve as the voice of the customer in product design, ensuring user needs are met.
* Provide input on design reviews, identify potential risks, and develop mitigation plans.
* Support preparation of compliance packages for product evaluation and certification.
* Lead the preparation of demos and company presentations.
* Oversee clinical studies involving the use of developed products.
* Maintain full compliance with quality, regulatory, health, and safety legislation.
* Ensure traceability of design development and control of changes.