LEX is currently seeking a Verification and Validation Engineer
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 working closely with the head of Quality and Engineering team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic platform.
Please make sure you read the following details carefully before making any applications.
About LEX Diagnostics
LEX Diagnostics is an ambitious, well-funded point-of-care diagnostics business. We believe that fast, accessible molecular diagnostics will have a fundamental impact on how infectious diseases are managed at point of care and beyond. Our technology is uniquely able to address this challenge and we are commercializing it with partners who share our ambition. Read more about LEX here.
Responsibilities
Responsibilities include:
1. Supporting with verification & validation to prepare the LEX System for clinical study and FDA approval.
2. Implement verification and validation test plans and protocols for the system/product, documenting all activities within the Quality Management System (eQMS).
3. Contribute to the development of Work Instructions and Standard Operating Procedures (SOPs).
4. Collaborate with the Engineering, Manufacturing, and Biology teams working towards regulatory submission and product launch.
5. Adhere to the requirements of working in an ISO 13485/FDA regulated environment.
Experience and Skills
Experience and skills required to be successful in this position:
* Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR 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 commercialization.
* Familiarity with operating within formal documentation systems, ideally under an eQMS.
About LEX Diagnostics & TTP Group
LEX Diagnostics is part of TTP Group, an employee-owned business. It operates from green surroundings in Melbourn, less than 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years.
Our Benefits Include
* Annual profit-related bonus
* Employer pension contribution of 12% of pensionable pay
* Private medical insurance for employees and dependents
* 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
* A wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock band!
* Local sports facilities and theater 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 commercialization. If you’re looking to join a diverse and growing team, then apply now! Every application will receive a response.
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