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. The role includes 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 with a solid understanding of New Product Development and experience in Transfer to Manufacture. Technically capable with in-depth knowledge, you will also have the confidence and ability to manage client expectations and projects, ensuring you adhere to short timescales whilst maintaining an excellent attention to detail.
 

About You
  • 2.2 Degree or above
  • 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
Our offices are based in a beautiful rural location close to Cambridge where we offer an exciting and challenging working environment.