Design Assurance / Design Control / Quality Engineer
Cambridge, United Kingdom | Cambridge Consultants
Job Description:54 people have viewed this job
Are you interested in undertaking the development of innovative medical products and equipment from concept to manufacture? Are you prepared to work with the team to solve technical challenges and maintain an overview of the whole system?
We are looking for a talented Design Assurance/Design Control/Quality Engineer to join our team within the Medical Technology Division.
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.
The Medical Technology Division's activities fall into four focus areas:
- Pharma and biotech
- Surgical systems
- Acute and critical care
- Life sciences
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. You will have opportunities to take leadership roles, be involved in systems engineering, and have direct client-facing roles.
- 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.
- 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
- Competitive salary reviewed anually
- Company profit share
- Generous pension
- Hybrid working model
- Flexible working hours and location
- 25 days annual leave plus public holidays, with flexibility to carry over / borrow
- Comprehensive insurance - Life, disability, private healthcare and travel insurance (business & leisure)
- Enhanced family leave benefit of 13 weeks full-pay parental leave for those that meet qualifying criteria
- Career development and training opportunities
- Social committee
- Discounted train season tickets, through Travel Plan Plus
- If travelling to Cambridge by train; Free shuttle service to/from Cambridge North train station, through Cambridge Science Park
- Whilst in the office; Free canteen - breakfast, lunch & refreshments
- A comprehensive relocation package is available, if applicable
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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