We are currently working on behalf of a client in Mildenhall area who are a precision medical device manufacturer looking to add an Engineer to their R&D team. This role will be a days-based role working 40hrs per week with a salary of up to £40,000 depending on experience. Key responsibilities for this role are as below: * Generating usability documentation for regulatory submission of the medical products in compliance with ISO 13485, IEC 62366 and other regulatory standards (e.g. MDR, FDA) * Planning, running and moderating use studies such as formative and summative evaluations * Working closely with the customers and clinical experts to gather to gather user needs and insights * Work closely with design, engineering and project teams to ensure user-centred design * Organise and participate in internal and customer-facing meetings * Conduct use-related risk analysis and contribute to the overall risk management process * Ensure that all activities align with relevant quality systems and regulatory frameworks * Occasional UK and international travel may be required to satisfy the needs of the project They are looking for an individual who ideally have: * Strong knowledge of medical device regulations (UKCA, MDR, FDA etc.) * Experience working with relevant usability and human factors standards and guidance such as IEC 62366 and HE75 * Hands-on experience in planning and conduct...