Job Title

Design Verification & Validation Engineer | 12 month contract | £350-500 per day | Outside IR35 | London | Immediate startOne 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.They're based in London, but have a flexible working model. You'll be working closely with various heads of department to engender a collaborative and productive working environment.They're 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 specificationsOversight of the completion of labelling and packaging design in alignment with the relevant medical device and pharma labelling standards and regulationsTo lead the design reviews for the device, ensuring the product design is evaluated against requirements detailed within the TRS and URSTo lead the design verification testing of the device and associated labelling and packaging.Coordinate the supply of raw materials for the manufacture of DV samplesEnsure test methods are documented, validated and staff are trained (training is recorded)Develop the design verification protocol, including traceability to the TRS and test reportsCoordinate internal and external testing in accordance with the protocolAnalyse test data and prepare a design verification reportTo lead the design validation of the device, including Clinical trialsAs above for design verification, plus:Liaison with the CRO, including the coordination of all documentation and evidence required for the clinical trialMaintain the design history file in accordance with 21 CFR part 820 requirementsManage product change control, in accordance with the relevant CLCC proceduresMaintain the Device Master Record in accordance with 21 CFR part 820 requirementsRegulatoryCollate 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.