Address
Form of work
SalaryCambridgeshire
GBP40k - GBP55k (dep on exp) + bonus and excellent benefits!
A fantastic opportunity for a Senior Verification & Validation Engineer has arisen at a Cambridge based cutting edge leading medical device development company whose innovative technology is reshaping the medical, life science and diagnostics sectors! You will be leading the verification and validation activities for this groundbreaking and market disruptive point-of-care diagnostics device!
As the Senior Verification & Validation Engineer, you will use your previous experience in product development within a regulated environment to draft V&V protocols and developing test methods and strategies.
You will play a crucial role within the company, to push forward the release of this new system playing a key role in shaping the future of diagnostic technology! Due to the imminent global release of this product, you will need to adhere to the requirements of medical device regulations ISO 13485/FDA environments.
As the Senior Verification & Validation Engineer, your responsibilities will include:
- Lead the planning of verification activities for the system, including both the Instrument and test consumable.
- Ensure tests are designed in alignment with product requirements will full traceability.
- Adhere to the requirements of working in an ISO 13485/FDA regulated environment.
- Implement verification and validation test plans and protocols for the system/product, documenting all activities within the Quality Management System (eQMS).
- Collaborate with the Engineering and quality departments to ensure test method, equipment and materials are available in line with company timelines.
- Analyse and interpret data with precision and contribute to design reviews and collaborative discussions.
The Senior Verification & Validation engineer will need the following skills and experience:
- An Engineering degree or equivalent hands-on experience.
- Recent and relevant practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment.
- Experience in writing, editing, or addressing product requirements.
- Proficiency in both Mechanical and Electrical Engineering disciplines.
- Track record of submitting regulated product approval packages, as a minimum under CE-IVD/IVDR, ideally under FDA 21CFR.
- Familiarity with operating within formal documentation systems, ideally under an eQMS.
Sound like you or someone you know?
If so, please do not hesitate to get in contact with Darren Holmes at Vector Recruitment Ltd on
(phone number removed) or (url removed)
