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Human Factors Engineer
Job Posted: 3 hours ago
Salary: £ 32,000 - 40,000 / Annum
Job Type: Permanent
Location: Mildenhall, Suffolk
Expire in: a month
Job Description
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 touchBefore You Apply
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