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Validation Engineer

4 months ago

Cambridge Cambridgeshire, United Kingdom LEX Diagnostics Full time

LEX is currently seeking a Verification and Validation Engineer who will actively engage in hands-on testing of the LEX diagnostic system. You will be joining the Verification and Validation Team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic platform.
You’ll work closely with the Head of Verification and Validation to develop testing strategies and methodologies with the wider LEX team to complete testing. 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, Manufacturing and Biology teams working towards regulatory submission and product launch.
Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/CFR21 regulated environment.
Previous experience in writing test protocols in line with Product Requirement Specifications.
Degree in Science or Engineering or possess equivalent relevant experience.
Experience in medical device development and commercialisation.
TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years. Annual profit-related bonus
~ Employer pension contribution of 12% of pensionable pay
~ Private medical insurance for employees and dependants
~ Free lunch and all-day refreshments
~ Life insurance worth 6 x salary
~25 days holiday with the option to carry over or bring forward 5 days
~ Enhanced maternity and paternity leave, with the option to return part-time for a year
~ Electric car leasing scheme
~ Cycle to work scheme
~ Public Transport Season ticket loan
~ Local sports facilities and theatre discounts and memberships as well as our own onsite gym to use


This is an exciting opportunity within the LEX Diagnostics team and to help and support us with achieving our goal to commercialisation.