About The Role
Working within our multidisciplinary teams on major Medical and Drug Delivery development projects, you will be responsible for the development, evaluation and auditing of technical documentation including remediation work for our clients and suppliers as well as internally. The role includes supporting a selection of clients on a range of products and processes primarily in the Drug Delivery sector. 

You will come from a Design and Development background and have a good understanding of New Product Development/Transfer to Manufacture of Medical Devices preferably including Combination Products. This is 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 as well as training and development opportunities. Positive, professional and confident you will have the opportunity to attend client meetings and lead projects in the future.

 
About You
  • 2.2 Degree or above
  • NPD & NPI/Transfer to Manufacture experience in the Medical Device or Combination Product fields 
  • Experience of submissions to regulatory authorities including EU, US and ROW is a bonus
  • Experience of working within ISO 13485 quality management system 
  • Experienced at developing content for Risk Management Files including; Plans, Hazard Assessments, Design FMEA, Process FMEA and Risk Reporting
  • Experienced at developing content for Design History and technical files
  • Ability to write technical documents in a methodical and timely manner 
  • Willingness to communicate/present to clients at all levels
  • A clear understanding of current Medical Device and Combination Product regulations
About Us
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. Our offices are based in a beautiful rural location close to Cambridge where we offer an exciting and challenging working environment.

In return for your hard work and insightful ideas you receive; Competitive salary, Discretionary bonus, 12% non-contributory pension, Private healthcare, 25 days holiday.