Design Verification Engineer

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

Job summary

An innovative firm is seeking a Design Verification & Validation Engineer for a 12-month contract in London. This role involves overseeing design outputs, leading design reviews, and ensuring compliance with medical device regulations. You'll collaborate with various departments to foster a productive environment while working on groundbreaking products that address critical needs in healthcare. If you have a strong background in V&V engineering and a passion for making a difference in the medical field, this opportunity is perfect for you!

Qualifications

• Experience in design verification and validation processes.
• Strong understanding of medical device regulations.

Responsibilities

• Lead design reviews and verification testing for medical devices.
• Coordinate internal and external testing and prepare reports.

Skills

Design Verification

Design Validation

Regulatory Compliance

Technical Documentation

Data Analysis

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

Design History File Management

Clinical Trial Coordination

Job description

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Base pay range

Direct message the job poster from RBW Consulting

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 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
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Quality Assurance, and Production

• Industries

  Medical Equipment Manufacturing

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