Senior Human Factors Specialist
We are seeking a highly skilled professional to lead the human factors process for a novel medical device.
Key Responsibilities:
* Ensure compliance with EU and FDA requirements from design phase to production.
* Coordinate user studies and develop project plans to meet performance, time, and cost targets.
* Develop and deliver design and risk management documentation for human factors, including market requirements, design specifications, and validation protocols.
* Act as the voice of the customer in product and user experience design.
* Identify potential design risks and develop mitigation plans.
* Support compliance package preparation for product evaluation and certification.
* Prepare demos for user studies, company presentations, and clinical studies.
* Maintain full compliance with quality, regulatory, health, and safety legislation.
* Ensure design development traceability and control of changes.
Requirements:
* Bachelor's degree in Human Factors or related field.
* 5+ years of experience in human factors engineering.
* Proven track record of delivering successful projects.
* Excellent communication and collaboration skills.
* Ability to work in a fast-paced environment.
What We Offer:
* Competitive salary and benefits package.
* Opportunity to work on cutting-edge medical devices.
* Collaborative and dynamic work environment.
* Professional development opportunities.