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Mechanical Engineer

2 months ago

Cambridge, United Kingdom Newton Colmore Full time

Mechanical Engineer - Medical Devices Validation

Newton Colmore is working with a medical devices company in Cambridgeshire, and we are looking for a mechanical engineer to join their verification and validation team.

In this Mechanical Engineer role, you will be working on novel and complex medical devices whilst collaborating closely with fellow engineers, external consultants, and suppliers to ensure the company's products deliver a step change.

Your work will be vitally important in ensuring the successful execution of validation and verification activities required ahead of regulatory approval, product launch, and mass manufacturing. This role will initially focus on an FDA submission and after this is complete, the role will naturally evolve, and you will take on extra responsibilities as the company moves to its next phase.

You will be heavily involved in readying the company's product for clinical trial, and the verification and validation test plans and protocols for the product, documenting all activities within the Quality Management System. Another key part of the role is the contribution to the Standard Operating Procedures.

To be considered for this opportunity you will need to have prior experience with medical devices and an ISO 13485 environment, coupled with expertise in writing test protocols and familiarity with QMS. Ideally this will be from a mechanical engineering background and any experience with CAD would be highly beneficial. For this role, we are ideally looking for a candidate who has 1-to-3 years' worth of experience.

The company are passionate about delivering a step-change for patients with their technology and they need great people to help them with this mission.

In return for your hard work the company offer a salary, tailored to your experience level, and a benefits package that includes bonuses, industry leading pension contributions, 25 days holiday and much more.

Matt Lowdon is taking lead on this assignment and so please do make a confidential application for more details.

Matt has been working with this company for over 12 years and can offer deep insights and knowledge throughout the interview process, with the aim of maximising your chances of securing this role.

Newton Colmore is a specialist executive search and talent solutions company dedicated to the medical devices and biotechnology sectors. Founded in 2015, we have helped our clients find expert scientists and engineers across the globe.