Product Validation Engineer - Medical Device
Biotechnology Life Sciences
Product Validation Engineer – Medical Devices
This is an exciting opportunity for an experienced product validation engineer to join a growing medical device company based in Southampton. Combining technical, clinical and management expertise to develop advanced, biometric sensors, the company are developing an innovative monitoring device to measure key indicators of fertility.
The Product Validation Engineer will join a talented engineering team to help realise the transition of a proven concept design into a manufacturable medical device that meets relevant regulatory requirements for clinical investigations and successful commercial launch. The main responsibilities of the role will include:
- Product verification and validation for medical device
- Managing multiple verification and validation activities for a single project
- Writing verification plans, protocols and reports
- Defining equipment needs, defining and constructing test equipment, set-up and execution of testing
- Electronic product experience would be advantageous;
- Experience of working with external contractors is desirable.
Ideally candidates will be educated to degree level (or equivalent) or possess similar qualification in technical/engineering discipline (biomedical, electronic, mechanical, materials), or a related subject.
Some other key experience needed for this role includes:
- Experience as a medical product validation engineer or similar experience in a technical role such as senior/design engineer essential
- Good working knowledge of applicable quality system standards and regulations (including, but not limited to: ISO13485, MDD/MDR and 21 CFR 820).
- Well organised, able to multi-task and work to tight deadlines under pressure;
- Flexible, open-minded and creative with innovative ideas, a can-do attitude, whilst being able to challenge and be challenged
- Ability to work effectively in a small team environment with a diverse group of people with minimal guidance
- Highly proficient in written and verbal communication with the ability to generate high-quality documentation and presentation for various audiences
- Ability to influence and build consensus across cross-functional groups
- Experience of creating of validation plans, protocols and reports for new products/production processes
This is a great opportunity to join an exciting start up at a pivotal period in the company’s growth. If this sounds like the opportunity for you, apply now with your CV, and feel free to contact Tom Kirkpatrick at CY Partners for more information.