CMR is now seeking a Design Quality Engineer for a key position within its Quality Department based in Cambridge to provide guidance and drive compliance on new and existing products and design processes.

This role is offered on a hybrid basis, with a minimum of 3 days a week being based in the office.

About CMR Surgical

CMR is an exciting and evolving company to be joining right now.  Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals.

At CMR we’re pushing boundaries – enhancing immense human skill with technology to deliver the best surgical care which is why we’re proud to be the Official Medical Device Partner of ParalympicsGB, the team of elite athletes that challenge perceptions of what humans can achieve. The team that inspires us with their determination, their precision and control.

We’re breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible. Come and join us and see what you’re capable of.

Responsibilities

We’re looking for someone who will be passionate about helping us deliver quality in everything we do. In this role, you’ll:

• Implement the defined design quality processes, procedures, and principles across the business, including involvement in design-related product changes.
• Work with project teams ensuring all verification, validation and review processes are robust and consistent.
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts.
• Support design verification testing providing guidance in developing and validating test methods, reviewing and approving verification records.
• Actively engage in the execution of the Quality Plan and Risk Management activities
• Work with various stakeholders including technology, manufacturing, customers, and regulatory bodies to facilitate corrective action
• Train and coach others in best practice and the required levels needed to maintain conformance with product and quality requirements
• Create a culture of continuous improvement
• Monitoring and reporting quality metrics in the areas of design and design controls

We’re a rapidly evolving company and roles can change and evolve. You’ll be willing to turn your hand to anything within the Design Quality remit that supports the team with delivering its objectives.

About you

Naturally, given what we do as a company, you’ll have a sound working knowledge of medical device manufacture within an accredited ISO 13485 quality management system or similar regulated industry. We’d also like you to have:

• A degree in science or engineering-related discipline and/or basic working knowledge of electronics, mechanics and software.
• Working knowledge and experience in new product design and development in a regulated environment, preferably medical device
• Knowledge of medical device regulations, MDR, MDSAP, ISO 13485 and other global laws and regulations and standards including 21 CFR Part 820, ISO 14971 (including FMEA, DFMEA, PFMEA), IEC 60601-1 and related particular standards
• The ability to demonstrate a hands-on approach to quality design and you won’t be afraid to get involved with any issues as they arise
• A dynamic and proactive outlook with strong problem-solving skills, a knowledge in quality problem solving tools such as 8D or Lean Six Sigma would be an advantage
• Ability to process lots of data and information, extract facts, determine a course of action and implement accordingly
• The willingness to take responsibility and effectively manage your time and multiple tasks to meet deliverables on time
• Familiarity with document management system, software, internal auditing is an advantage
• An excellent communicator with strong written and verbal communication skills

At CMR we’re building a diverse, inclusive, and authentic workplace; what matters most to us is that you identify with our values and are passionate about making a difference so don’t be put off applying if your experience isn't perfectly matched with this role.

We’d really like to hear from applicants from underrepresented groups and we recognise everyone has individual personal circumstances, so we’re open to discussing reduced / flexible / hybrid working hours for this role.

Why Join Us?

We offer a competitive salary and a great benefits package including a bonus, non-contributory pension, private healthcare which covers pre-existing conditions, annual personal day for every employee to use however they wish and enhanced global parental leave pay.

We recognise that everyone has a life outside of work and at times we can experience things which are significant and can impact on our working lives. We’ve just launched our Global Parental Leave and Health and Wellbeing leave supporting our colleagues going through the menopause, fertility cycles or pregnancy loss and those going through gender reassignment; allowing them time to look after themselves and those close to them.  

Interested? We’d love to hear from you!