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 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 conducting user studies
• Knowledge of use risk management processes
• Proficiency in Microsoft Office and technical writing

For further informtion or a full job spec, please get in touch!