We are looking for an expert on reprocessing, sterilisation and biocompatibility. Based at our headquarters in Cambridge, this role will work across multidisciplinary teams to integrate novel products and product designs and/or process changes through biological risk assessments, verification and/or validation activities. Execution of these tasks will require management of test houses, development of reprocessing methods, input to test protocols and reports, in accordance with country specific requirements, as well as generation of technical summaries for regulatory submissions.
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 focussed. 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.
We are looking for an expert on reprocessing, sterilisation and biocompatibility. Based at our headquarters in Cambridge, this role will work across multidisciplinary teams to integrate novel products and product designs and/or process changes through biological risk assessments, verification and/or validation activities. Execution of these tasks will require management of test houses, development of reprocessing methods, input to test protocols and reports, in accordance with country-specific requirements, as well as generation of technical summaries for regulatory submissions.
- Working knowledge of industry regulations, standards, and guidance for medical device reprocessing, sterilisation and biocompatibility.
- Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and external suppliers, including test houses.
- Develop and/or optimise reprocessing strategies and instructions, in collaboration with the engineering and usability teams for new or existing products.
- Manage multiple cleaning, disinfection, sterilisation validations as well as compatibility investigations with reprocessing agents and performance testing with diligence.
- Support reviews and troubleshooting of reprocessing practices to make recommendation for improvements.
- Manage capture of all relevant information for material characterisation, processing specification and chemical analysis required for reprocessing, sterilisation and biocompatibility risk assessments.
- Conduct biological, reprocessing, sterilisation risk assessments and input to reprocessing-related UFMEAs.
- Provide technical input for design, materials and product requirements for optimised reprocessing, sterilisation and biological safety.
- Generate technical summaries to support regulatory submission, approvals, and strategies.
- Update relevant documentation for existing products to ensure compliance with country-specific requirements and international standards.
- Provide technical support for any non-conformance and CAPA activities.
We’re a high growth company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Reprocessing and Biocompatibility remit that helps the team deliver its objectives.
A natural communicator hopefully goes without saying, but in addition we’d like you to have:
- A minimum of a Bachelor’s degree (or equivalent) in Science, Microbiology, Chemistry or relevant technical discipline.
- Experience in a similar or related role in industry, with a preference for the medical device field.
- Strong expertise in Sterilisation, Reprocessing and Biocompatibility and Regulatory Submissions
- Proficient in Microsoft and other software applications.
- Detail oriented with excellent analytical skills and critical thinking.
- Excellent organisational skills, with the ability to prioritise and to manage multiple project timelines.
- Excellent written and oral communication skills, including effective communication with cross functional teams.
- Ability to work independently as well as in a team in a fast-paced environment.
- A genuine desire to help and support team members so that we can all achieve our best.
We offer a competitive salary and a great benefits package (including cycle-to-work scheme, life assurance, and childcare vouchers, and 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.