About The Role
Working within and leading our multidisciplinary teams on major product development projects, you will be responsible for Project and Client Management. A hands-on role you will still be pivotal in the performing of quality tasks and responsibilities including remediation work and the development, evaluation and auditing of Design History Files (DHF) for a wide range of high profile and loyal clients as well as our suppliers and internal projects. 

Our projects create challenging and demanding opportunities, you will support the development 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 tight deadlines and budgets.

You will have an influence and voice in shaping our quality team and service to meet our clients’ needs and expectations. A fundamental player in taking ownership of business development activities, devising strategies and processes. We are hugely successful and our staff and clients are at the heart of our company’s DNA. We have a passion for innovation and have a commitment to excellence. Experiencing transformational growth, to support this we are investing in our people and services. 
About You
You will have:
  • 2.2 Degree or above
  • NPD & NPI/Transfer to Manufacture experience in the medical device and/or pharmaceutical manufacturing/development area
  • Experience of submissions to regulatory authorities including EU, US and ROW
  • Experience of working within an 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 
  • Ability to communicate/present to clients at all levels
  • Ability to lead projects and manage clients, taking responsibility for quality, time and profit 
  • Appraising and coaching other members of the team
  • Able and willing to travel regularly in the UK and/or overseas for client meetings and business development activities
  • 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.