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Job description

Working within our multidisciplinary teams on major product development projects, you will be responsible for the development, evaluation and auditing of Design History Files (DHF) including remediation work for our clients and suppliers as well as internally. Supporting a selection of clients on a range of products and processes in primarily the medical sector.

You will come from a Design and Development background and have a good understanding of New Product Development/Transfer to Manufacture. A fantastic time to join the team, you will have numerous projects to get stuck into and immediately add value. This role will suit an ambitious individual who is looking for career advancement and training and development opportunities. Positive, professional and confident you will have the ability to attend client meetings and lead projects in the future.

You will have:

  • 2.2 or above in an Engineering or Science Degree

  • R&D/Product Development experience in the medical device or IVD development area

  • Experience of working to regulatory requirements including EU, US and ROW

  • Experience of working within ISO 13485 quality management system

  • Experience of developing content for Design History and technical files (e.g Design inputs, verification and validation documents etc)

  • Experience of developing content for Risk Management Files including; Plans, Hazard Assessments, Design FMEA, Process FMEA and Risk Reporting

  • Ability to write technical documents in a methodical and timely manner

  • Willingness to communicate/present to clients at all levels

  • Experience in combination devices would be advantageous.

  • A technical understanding of electro-mechanical devices is desirable

We look after you:

We are an employee owned company with our staff at the centre of our strategy. Employee ownership allows us to maintain full control over the direction of our business and our creative culture.

In return for your hard work and insightful ideas, you receive a competitive salary, discretionary bonus, 12% non-contributory pension, private healthcare and 25 days holiday

Further details:

If you have the skills and personal qualities to succeed in this role, please email your CV with current remuneration details to Tonya Williamson at recruitment@cambridge-design.com

We welcome international applications, but at this time, we are unable to offer sponsorship for work permits, so you will need to have the full right to live and work in the UK. Unfortunately, your application will be rejected if you do not have these rights.

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