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- Tasks: Lead design verification and validation for innovative medical devices.
- Company: Join a pioneering company transforming the pharmaceutical industry in London.
- Benefits: Enjoy flexible working, competitive pay, and a chance to make a real impact.
- Why this job: Be part of a groundbreaking project that addresses critical healthcare needs.
- Qualifications: Experience in design verification for combination devices or pharmaceuticals is preferred.
- Other info: Immediate start available for a 12-month contract, outside IR35.
The predicted salary is between 70000 - 105000 £ per year.
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 are based in London, but have a flexible working model. You will be working closely with various heads of department to engender a collaborative and productive working environment. They are 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.
- 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.
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Verification & Validation Engineer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards related to medical devices and pharmaceuticals, such as 21 CFR part 820. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the V&V engineering field, especially those who have experience in combination devices or pharmaceutical products. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences with design verification and validation processes. Be ready to share specific examples of how you've led design reviews or coordinated testing, as this will showcase your hands-on expertise.
✨Tip Number 4
Research the company’s recent projects and innovations in the medical device sector. Showing that you understand their work and how you can contribute will set you apart from other candidates.
We think you need these skills to ace Design Verification & Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in design verification and validation, particularly in combination devices or pharmaceutical products. Use specific examples that demonstrate your skills and achievements in these areas.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role. Mention how your background aligns with the company's innovative approach and the critical area they are addressing.
Highlight Regulatory Knowledge: Since the role involves compliance with medical device regulations, emphasise your understanding of standards such as 21 CFR part 820. Include any relevant certifications or training that showcase your expertise in this area.
Showcase Collaboration Skills: The job requires working closely with various heads of department. Provide examples in your application that demonstrate your ability to work collaboratively in a team environment, especially in high-stakes projects.
How to prepare for a job interview at RBW Consulting
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Design Verification & Validation Engineer. Familiarise yourself with key concepts like design outputs, labelling standards, and regulatory requirements. This will help you answer questions confidently and demonstrate your knowledge.
✨Prepare for Technical Questions
Expect to be asked about your experience with design verification testing and clinical trials. Brush up on relevant methodologies and be ready to discuss specific projects you've worked on. Providing concrete examples will showcase your expertise.
✨Showcase Collaboration Skills
Since the role involves working closely with various heads of department, be prepared to discuss how you've successfully collaborated in past roles. Highlight any experiences where you facilitated teamwork or resolved conflicts to create a productive environment.
✨Ask Insightful Questions
At the end of the interview, ask questions that show your interest in the company and the role. Inquire about their innovative products, the team dynamics, or future projects. This not only demonstrates your enthusiasm but also helps you gauge if the company is the right fit for you.
