We’re looking for a bright, ambitious Validation Engineer, specialising in Medical Devices or Robotics Manufacture, to join our growing manufacturing team. You will be a core member of the manufacturing engineering team supporting the validation and control of new and existing processes used for the assembly of our cutting-edge robotic surgical system.
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 breathtaking 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, people focused and fair and responsible. If you share these values, 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 validating the processes used in the manufacture of our innovative and complex electro-mechanical products and systems, working day to day on:
- Defining validation requirements for designs transferred to manufacturing
- Generating validation protocols for IQ, OQ and PQ
- Defining tests for process validation
- Executing validation protocols and generating reports
- Maintaining the validated state of existing systems and processes by reviewing changes and process stability data
- Implementing Statistical Process Control
- Carrying out data analysis on processes to determine their performance against pre-defined requirements
- Maintaining Validation Master Plans
- Providing feedback to design teams on opportunities to improve manufacturability
- Working with domestic and international contract manufacturers to align validation approaches
- Generating supporting documentation such as risk assessments, risk management (FMEA), control plans, process and equipment specifications and schematic drawings.
We’d expect you to have a relevant degree or experience from a relevant industry at a similar level. Naturally you’ll also be a great team player with a strong work ethic and a demonstrable determination to produce high quality results.
We’re also looking for you to have experience in some or all of the below:
- Manufacturing process validation for medical devices or robotics.
- Risk management to ISO 14971.
- Working in medical devices industry, particularly ISO13485 and/or FDA CFR21 Part 820 in line with Good Manufacturing Practice.
- The requirements of change control and documentation control.
- Working within new or established production environments.
- Validation test specification and product requirement evaluation
We offer a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our legendary monthly 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.