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We are looking for a talented Design Assurance/Quality Engineer to join our team within the Medical Technology Division.

Our Medical Technology Division undertakes the development of innovative medical products and equipment from concept to manufacture. The projects often involve considerable technical challenges. The Division's activities fall into four focus areas:

  • Drug Delivery Devices
  • Surgical and Interventional Products
  • Medical Diagnostics and Instrumentation
  • Wireless devices / eHealth

You will make a significant contribution to major medical technology development projects. You will translate regulatory requirements into product requirements for innovative medical products, and ensure compliance to relevant standards and regulations throughout, with a particular focus on risk management and design verification.

What we can offer

As a Design Assurance Engineer, you will be involved in a wide range of projects, from requirements capture through to manufacture. You will apply your regulatory knowledge to device development projects across the whole Division, liaising with scientists, engineers and Quality Assurance personnel both within Cambridge Consultants and within our client organisations.

You will be responsible for conducting research and writing requirements, to then review them for traceability and testability. You will lead product risk management activities according to ISO14971 (including creation of Risk Management Plan, FMECAs, Fault Tree Analysis and Risk Management Report).

You will have the opportunity to help clients optimise their medical development processes. You will plan verification programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria. You will take an active role in Design Reviews to assess quality and compliance and create essential requirements checklists, as well as supporting the creation of technical files/design history files, including the review of those of our clients.

We have a culture that encourages our team members to take on the level of responsibility that suits them and provide support to learn and develop new skills both technically and professionally.

What you can bring

You will have a degree in Engineering or a related technical discipline, with significant experience of risk management with regards to Medical Product development (according to ISO14971) and a strong understanding of the MDD, MDR, ISO 13485 and FDA QSR.

You will also have experience of working in multi-disciplinary teams in at least one of the Division’s four focus areas, have working knowledge of Design Verification, and the ability to review the work of others.

The following are not required, but any experience in these areas would be advantageous:

  • Knowledge and experience of implementing IEC 60601 and IEC 62304
  • Experience of liaising with the US FDA with regards to device submissions
  • Experience of Design Validation
  • Experience of design and development of, and regulatory submission for combination products
  • Experience of regulatory requirements regarding testing of pharmaceuticals
  • Experience of GMP, including manufacturing line qualification processes

 

NO AGENCIES PLEASE

 

Learn about Life at CCWhat to expect when applying

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Benefits

  • Competitive salary, based on merit and reviewed annually
  • Company profit share scheme in addition to basic salary
  • Pension scheme
  • Life, disability and travel insurance, plus private healthcare
  • Free canteen - breakfast, lunch and refreshments
  • 25 days annual holiday plus public holidays, with flexibility to carry over / borrow
  • Relocation assistance if applicable
  • Excellent career development and training opportunities
  • Flexible working hours
  • Social committee
  • Discounted train season tickets, through Travel Plan Plus
  • Free shuttle service to/from Cambridge North train station, through Cambridge Science Park

Future prospects

Cambridge Consultants is committed to developing its employees' careers and has a flexible policy for individual capabilities and preferences. Promotion is linked to merit.

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