Human Factors Engineer

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 RandD 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 conducting user studies Knowledge of use risk management processes Proficiency in Microsoft Office and technical writing ..... full job details .....