Usability Engineer - Medical Industry

Usability Engineer - Medical Industry

Mildenhall, Suffolk

£35,000 per annum

We're hiring a Usability Engineer for a world class, global medical manufacturing company.

As the Usability Engineer you will play an integral role leading the wider usability team and generation of the required technical documentation to bring new medical devices from concept, through regulatory approvals and into commercial products

Job Role:

• Generating usability documentation for regulatory submission of the medical products line with ISO 13485 and other medical device regulatory requirements.


• Leading, running and moderating use studies such as formative and summative evaluations.


• Working closely with the customers and clinical experts to gather relevant information.


• Work closely with the project and wider teams to create a device that meets the customer’s/users needs.


• Attend and organise regular internal and customer meetings.


• Risk management and hazard analysis activities.


• To function within all regulatory requirements and quality systems, particularly related to medical devices.


• Occasional UK travel may be required to satisfy the needs of the project.

Skills Required:

• Bio Engineering/Medical based Degree or equivalent qualification.

• Practical experience within medical device development field.

• Experience in project management (ideally of medical device projects).

• Knowledge of medical device regulations (UKCA, MDR, FDA etc.).

• Knowledge of design and development risk management processes.

• Documentation writing skills and ability to use MS Office programs.