We’re looking for a bright, ambitious Process Engineer to join our growing manufacturing team. You will be involved in integrating, testing and establishing manufacturing of our cutting-edge robotic technology for keyhole surgery.
Why join us?
CMR is one of the UK’s most exciting companies to be joining right now. The scale of our ambition to build a world-class medical devices company in Cambridge is matched only by the breath-taking innovation that underpins our next generation of surgical robot. We’re an award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.
Our values are ambitious, humble, fair and responsible and people focused. If you share these values and our passion for improving lives, and have the skills to make a real difference to the way minimal access surgery is developed and delivered then it’s a great time to join us.
You’ll be part of a multi-disciplinary manufacturing team testing and integrating innovative and complex electro-mechanical products and systems, working day to day on:
- Process and equipment validation:
- Writing and executing FAT, SAT, IQ, OQ and PQ protocols
- Identifying test methods and specifications to demonstrate product compliance to design.
- Supporting the transfer of established designs from development to production:
- Developing pilot processes for new product designs and design changes.
- Providing DfX input to the product design, supply chain and servicing processes.
- Generating process design documentation, work instructions and specifications.
- Monitoring process performance ensuring a consistent output is achieved:
- Analysing data to determine process stability
- Raising non-conformance reports and carrying out root cause analysis on non-conforming processes or components in line with the defined CAPA process.
- Identifying and working to implement improvements in production work flows and testing methodologies (with both internal and external partners).
- Carrying out risk management activities such as Health and Safety Risk assessments and Process FMEA including the implementation and communication of mitigation actions.
- Testing and commissioning of robotic assemblies.
- Generating reports and communicating findings to relevant stakeholders.
We’d expect you to have a good (first or upper second) relevant degree from a top university. In addition, you’ll have at least two years of experience from a relevant industry. Naturally you’ll also be a great team player with a strong work ethic and a demonstrable determination to produce high quality results.
- Generating test protocols and manufacturing documentation.
- Working in medical devices industry, particularly ISO13485 and/or FDA CFR21 Part 820 manufacturing environment.
- Experience working within new or established production environments.
- Hand assembly, semi- and fully automated manufacturing systems.
- The requirements of change control and documentation control.
- The management of calibration and maintenance of test and measurement equipment.
- Statistical Process Control.
- Lean and Six Sigma.
- Defining measuring and analysing KPIs relevant to manufacturing performance.
- Manufacturing scale up and capacity analysis.
- Python programming.
- Querying databases with Structured Query Language.
We offer a competitive salary and a great benefits package (including pension, cycle-to-work scheme, life assurance, and medical insurance – as well as our now famous monthly company BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.