We are currently working on behalf of a client in the Mildenhall area who are a precision medical device manufacturer looking to add an Engineer to their R&D team.
This role will be days-based, working 40 hours per week, with a salary of up to £40,000 depending on experience.
Responsibilities
* Generating usability documentation for regulatory submission of 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 customers and clinical experts to gather user needs and insights
* Working closely with design, engineering and project teams to ensure user-centred design
* Organising and participating in internal and customer-facing meetings
* Conducting use-related risk analysis and contributing to the overall risk management process
* Ensuring 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
Qualifications
* Strong knowledge of medical device regulations (UKCA, MDR, FDA etc.)
* Experience with 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
Additional information
For further information or a full job spec, please get in touch
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