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Verification Engineer - Cambridge, Cambridgeshire, United Kingdom - LEX Diagnostics
Description
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.
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 commercialising it with partners who share our ambition.
You can read more about LEX here.You'll develop testing strategies and methodologies with the wider LEX team to complete testing and draft verification and validation protocols.
Your contributions will be crucial in ensuring the successful execution of validation and verification activities required ahead of regulatory approval and product launch.
Responsibilities include:
Supporting with verification & validation to prepare the LEX System for clinical study and FDA approval.
Implement verification and validation test plans and protocols for the system/product, documenting all activities within the Quality Management System (eQMS).Contribute to the development of Work Instructions and Standard Operating Procedures (SOPs).Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch.
Adhere to the requirements of working in an ISO 13485/FDA regulated environment.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 commercialisation.
Familiarity with operating within formal documentation systems, ideally under an eQMS.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.
Drawing upon the expertise of its consultants in the Life Science sector, and the management experience of a company with a 30-year track record of developing breakthrough technology and creating ambitious tech businesses, TTP Group invested core IP and staff into LEX in 2020.
Our benefits include:
Annual profit-related bonusEmployer pension contribution of 12% of pensionable payPrivate medical insurance for employees and dependantsFree lunch and all-day refreshmentsLife insurance worth 6 x salary25 days holiday with the option to carry over or bring forward 5 daysEnhanced maternity and paternity leave, with the option to return part-time for a yearElectric car leasing schemeCycle to work schemePublic Transport Season ticket loanA wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock bandLocal sports facilities and theatre discounts and memberships as well as our own onsite gym to useThis is an exciting opportunity within the LEX Diagnostics team and to help and support us with achieving our goal to commercialisation.
