Design Verification & Validation Engineer | 12 month contract | £350-500 per day | Outside IR35 | London | Immediate start One of my long-standing clients is looking for a V&V engineer as they transfer into manufacturing, ideally with a background in combination devices/pharmaceutical products. Theyre based in London, but have a flexible working model. Youll be working closely with various heads of department to engender a collaborative and productive working environment. Theyre true innovators into a critical area of unmet need, with a genuinely ground-breaking product. Job overview: Oversight of completion of design outputs, including technical drawings, product and component specifications Oversight of the completion of labelling and packaging design in alignment with the relevant medical device and pharma labelling standards and regulations To lead the design reviews for the device, ensuring the product design is evaluated against requirements detailed within the TRS and URS To lead the design verification testing of the device and associated labelling and packaging. Coordinate the supply of raw materials for the manufacture of DV samples Ensure test methods are documented, validated and staff are trained (training is recorded) Develop the design verification protocol, including traceability to the TRS and test reports Coordinate internal and external testing in accordance with the protocol Analyse test data and prepare a design verification report To lead the design validation of the device, including Clinical trials As above for design verification, plus: Liaison with the CRO, including the coordination of all documentation and evidence required for the clinical trial Maintain the design history file in accordance with 21 CFR part 820 requirements Manage product change control, in accordance with the relevant CLCC procedures Maintain the Device Master Record in accordance with 21 CFR part 820 requirements Regulatory Collate the Technical File in accordance with the relevant regulations (could be UK, EU and / or US) Please apply right away to be considered for this great opportunity.