Please send applications to [email protected]
JEB Technologies is looking for an enthusiastic usability engineer to join their rapidly growing team in medical device development. JEB Technologies specialise in developing and manufacturing an array of devices that improve medical treatment and patient wellbeing. At JEB Technologies, a usability engineer is expected to take 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.
Responsibilities:
- 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.
Guidance, support and/or training will be provided to assist carrying out these responsibilities.
As a medical device manufacturer, our design and development processes comply with ISO 13485 and global regulatory requirements.
Qualifications and Experience:
This position will require organisational and communication skills (verbal and written), problem-solving skills, cross-functional teamwork and the ability to work independently.
The usability engineer would have:
- Minimum of 2yrs experience and relevant qualifications in usability and human factors engineering.
- Practical experience within medical device development field.
- 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.
- Experience in planning and conducting user studies.
- Knowledge of use risk management processes.
- Documentation writing skills and ability to use MS Office programs.
Job category: Usability Engineer
Department/ Group: Medical
Location: Mildenhall, Suffolk
Position Type: Permanent Shift
Please send applications to [email protected]