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