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- Tasks: Lead design verification and validation for innovative medical devices.
- Company: Join a pioneering company transforming the pharmaceutical industry.
- Benefits: Flexible working model with competitive pay, £350-500 per day.
- Why this job: Be part of a groundbreaking project addressing critical healthcare needs.
- Qualifications: Experience in combination devices or pharmaceutical products is essential.
- Other info: Immediate start available for the right candidate.
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.
Lead Verification and Validation Engineer employer: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Verification and Validation Engineer
✨Tip Number 1
Network with professionals in the medical device and pharmaceutical sectors. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends, which can give you an edge during interviews.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards relevant to combination devices and pharmaceuticals, such as 21 CFR part 820. This knowledge will not only boost your confidence but also demonstrate your commitment to the role.
✨Tip Number 3
Prepare to discuss your experience with design verification and validation processes in detail. Be ready to share specific examples of how you've led projects or collaborated with cross-functional teams to achieve successful outcomes.
✨Tip Number 4
Research the company’s recent innovations and products. Understanding their mission and the challenges they face will allow you to tailor your conversation and show how your skills align with their goals during the interview.
We think you need these skills to ace Lead Verification and Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in verification and validation, particularly in combination devices or pharmaceutical products. Use specific examples that demonstrate your expertise in design outputs and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention your understanding of the medical device industry and how your skills align with the responsibilities outlined in the job description.
Highlight Collaborative Experience: Since the role involves working closely with various heads of department, emphasise any previous experience you have in collaborative environments. Provide examples of how you’ve successfully worked in teams to achieve project goals.
Showcase Regulatory Knowledge: Demonstrate your familiarity with relevant regulations such as 21 CFR part 820. Include any specific experiences where you managed product change control or maintained design history files, as this will be crucial for the role.
How to prepare for a job interview at LinkedIn
✨Understand the Role Thoroughly
Before the interview, make sure you have a solid grasp of the responsibilities and requirements of the Lead Verification and Validation Engineer position. Familiarise yourself with key terms like TRS, URS, and 21 CFR part 820, as well as the specific regulations related to medical devices and pharmaceuticals.
✨Showcase Your Experience
Prepare to discuss your previous experience in verification and validation, particularly in combination devices or pharmaceutical products. Be ready to provide examples of how you've led design reviews or coordinated testing, as this will demonstrate your capability to handle the tasks outlined in the job description.
✨Emphasise Collaboration Skills
Since the role involves working closely with various heads of department, highlight your ability to foster collaboration and communication. Share examples of how you've successfully worked in cross-functional teams to achieve project goals, as this will resonate well with the company's emphasis on a productive working environment.
✨Prepare Questions for Them
At the end of the interview, you'll likely be asked if you have any questions. Prepare thoughtful questions about the company's innovative projects, their approach to regulatory compliance, or how they envision the role evolving. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
