Design Verification & Validation Engineer

RBW Consulting; London; Hybrid; GBP 125,000 - 150,000; Full time

Job summary

An innovative firm is seeking a Design Verification & Validation Engineer to join their team on a 12-month contract. This role involves overseeing design outputs, leading design reviews, and ensuring compliance with regulatory standards for combination devices and pharmaceutical products. The ideal candidate will have a strong background in V&V processes and experience with clinical trials. With a flexible working model and a focus on collaboration, this is an exciting opportunity to contribute to a groundbreaking product in a critical area of unmet need. Apply now to be part of this transformative journey!

Qualifications

• Experience in design verification and validation for medical devices.
• Strong understanding of regulatory standards for pharmaceuticals.

Responsibilities

• Oversee design outputs and ensure compliance with standards.
• Lead design reviews and verification testing for medical devices.

Skills

Design Verification

Design Validation

Regulatory Compliance

Technical Documentation

Clinical Trials Coordination

Education

Degree in Engineering or Life Sciences

Certification in Regulatory Affairs

Tools

Design History File Management

Technical File Compilation

Job description

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.

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 ofdesign outputs, including technical drawings, product and component specifications
• Oversight of the completion oflabelling and packagingdesign in alignment with the relevant medical device and pharma labelling standards and regulations
• To lead thedesign reviewsfor the device, ensuring the product design is evaluated against requirements detailed within the TRS and URS
• To lead thedesign verificationtesting 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 thedesign validationof 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 thedesign history filein accordance with 21 CFR part 820 requirements
• Manage productchange control, in accordance with the relevant CLCC procedures
• Maintain theDevice Master Recordin accordance with 21 CFR part 820 requirements

Regulatory

• Collate theTechnical Filein accordance with the relevant regulations (could be UK, EU and / or US)

Please apply right away to be considered for this great opportunity.