About The Role
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.
 
 
 
About You
You will have:
  • 2.2 or above in an Engineering or Science Degree
  • NPD & NPI/Transfer to Manufacture experience in the medical device development area
  • Experience of submissions to regulatory authorities including EU, US and ROW
  • 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
  • Desire to lead projects, taking responsibility for quality, time and profit 
  • Experience in combination devices would be advantageous
  • A technical understanding of electro-mechanical devices is desirable 
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.

With our offices in a beautiful rural location close to Cambridge, we offer an exciting and challenging working environment where development timescales are short and the specifications demanding but rewarding. An excellent opportunity to join a technical consultancy that’s exciting and going places!