Design Assurance Engineer

Design Assurance / Design Control / Quality Engineer

Do you want to use your skills and experience to bring ground-breaking medical devices and systems to life? In our Healthcare business unit, we solve complex, multi-disciplinary problems alongside our clients to bring world-changing technology to market.

We are looking for a keen, quality minded applicant to join our team within Healthcare as a Design Assurance/Design Control/Quality Engineer.

You will make a significant contribution to major medical technology development projects, which cover all stages of the development life cycle. You will be key in helping projects document the development of a range of medical devices, ensuring it is done to agreed timelines, and in line with our internal processes. You will increase your experience in applying standards and regulations to help realise novel medical technologies for our clients around the world.

As part of the role, you will have the opportunity to work on development projects in areas such as:

• Drug delivery
• Digital surgery
• Smart implants
• Diagnostics and monitoring

Role description

As a Design Assurance Engineer, you will be involved in a range of projects, including some of our biggest and most complex development projects, helping throughout the design process, from requirements capture through to manufacture. You will liaise with scientists, engineers, and Quality Assurance personnel both within Cambridge Consultants and within our client organisations providing your knowledge to forward projects.

You will also be responsible for taking lead roles in key internal projects which help keep our processes at the forefront of standard and regulations updates.

You will be involved in researching applicable product standards and regulations, translating them into requirements, and reviewing them for traceability and testability. You will take a role in product risk management activities according to ISO 14971 and ensuring the appropriate members from the project team and client are involved.

You will help to plan verification programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria. You will take an active role in or lead Design Reviews to assess quality and compliance.

We have a culture that encourages our team members to take on the level of responsibility that suits them and provides support to learn and develop new skills both technically and professionally. You will have opportunities to take leadership roles, be involved in systems engineering, and have direct client-facing roles which may include sales activities. Mentoring from more senior Design Assurance Engineers and shadowing on projects will also increase your knowledge and understanding of the role.

What you can bring

Our successful candidate will be excited by innovation in a regulated world, and how to adapt to meet the needs of clients, project teams, and the changing regulatory environment. You will be enthusiastic to use your skills for product development to help guide our teams of engineers, scientists, and designers to deliver the world-class service Cambridge Consultants is known for.

What you’ll bring to the role…

• A degree in a scientific field or a related technical discipline
• Knowledge of the requirements of medical device quality systems (e.g., MDR, ISO 13485 and FDA QMSR)
• Enjoyment in being a team player, with excellent communication skills, allowing you to communicate with all levels with Cambridge Consultants and client organisations
• Knowledge of testing, including Good Lab Practices
• Ability to independently plan, organise and prioritise own time to achieve a high level of productivity

Even better if you have, but we would still encourage you to apply without…

• Awareness of key regulations/standards that may impact medical device development, and where to search for them – including AI and cybersecurity
• Awareness of technical file/Design History File documents, and their creation of
• Experience of running test programmes and verifying products against requirements and regulations
• Ability to get involved in writing of proposals and sales calls with prospective and returning clients
• Workstream or project leadership experience