Senior Human Factors Engineer
We are seeking a Senior Human Factors Engineer to join our team at a high potential startup.
About the Role
This position will report to the R&D Director and be responsible for developing user requirements for a device.
Main Responsibilities:
* Lead the human factors process for a novel medical device, ensuring compliance with internal procedures, EU, and FDA requirements from design phase through production.
* Coordinate user studies and develop project plans to meet performance, time, and cost targets.
* Develop and maintain design and risk management documentation for human factors, including market requirements, design specifications, verification, and validation protocols and reports.
* Serve as the voice of the customer in product and user experience design for a novel medical device.
* Provide input during design reviews and identify potential design risks, developing mitigation plans.
* Support preparation of compliance packages for product evaluation and certification.
* Prepare demos for user studies, company presentations, and other purposes.
* Lead clinical studies involving the use of developed products.
* Ensure full compliance with quality, regulatory, health, and safety legislation, as well as traceability of design development and control of changes.