Design Assurance Engineer

Introduction

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

We are looking for a talented Design Assurance/Design Control/Quality Engineer to join our team.

You will make a significant contribution to major medical technology development projects, which cover all stages of the development life cycle. You will apply your knowledge of standards and regulations along with your problem-solving skills to realise novel medical technologies for our clients around the world.

Across healthcare, you will have the opportunity to work on development projects in areas such as:

• Pharma and biotech

• Digital surgery

• Smart implants

• Life sciences

• Ophthalmology

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, applying your expertise 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 be responsible for researching applicable product standards and regulations, translating them into requirements, and reviewing them for traceability and testability. You will lead product risk management activities according to ISO 14971 (including creation of Risk Management Plans, risk analyses, and Risk Management Reports), ensuring the appropriate members from the project team and client are involved.

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 or lead Design Reviews to assess quality and compliance. As a Design Assurance Engineer, you will author key regulatory documentation such as the General Safety and Performance Requirements checklists, as well as supporting the creation of technical files/design history files, including the review of our client’s files.

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.

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 knowledge of 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

• A thorough knowledge and understanding of the requirements of medical device quality systems (e.g., MDR, ISO 13485 and FDA QSR)

• Appreciate working in multi-disciplinary device design teams, leading key development activities such as requirements writing and risk management to ISO 14971

• Experience of writing and reviewing design documentation for inclusion in Design History/Technical Files

• Enjoyment in being a team player, with excellent communication skills, allowing you to communicate with all levels with Cambridge Consultants and client organisations

• Working knowledge of Design Verification activities

• 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…

• Knowledge and experience of implementing IEC 60601 and IEC 62304

• Experience of liaising with regulators/Notified Bodies with regards to device submissions, including combination products

• Ability to get involved in writing of proposals and sales calls with prospective and returning clients

• Project managed or technically led projects, including mentoring roles

• Ability to manage and develop capabilities and key client accounts

• Experience of Design Validation

• Experience of regulatory requirements regarding testing of pharmaceuticals, GMP or line qualification process