About the role

Within our Operations team, we are looking for a candidate that can lead change and make iterative improvements to projects to grow the production capacity of Creo Medical. Through implementing design changes and improving Creo products in line with the business needs, this role will help to maintain the state-of-the-art products produced by Creo and to initiate the future development of projects.

A can-do attitude and ability to meet and maintain the highest levels of quality are key for this role. Whilst working with a small of engineers to complete projects to agreed timescales. The role will blend technical engineering, with continued compliance to changing regulatory requirements. Whilst bringing efficiency to a rapidly growing company with a real clinical demand for products.

Key Responsibilities

• Design and Development activities for an endoscopic electro-surgical accessory product in accordance with Creo Medical’s ISO13485
• Quality Management System, followed by Verification and Validation (V&V) activities, completion of the technical file and transfer to manufacturing.
• Drafting and agreement of design and development, design proving and V&V documentation – including specifications, protocols and test records.
• Development and execution of V&V test fixtures and tests.
  Design, perform and document a sequence of bench tests to characterise the thermal effects of the device compared with predicates.
• Support the generation of an FDA 510(k) submission for the device.
• Execution of design improvements and cost-out activities for an endoscopic electro-surgical accessory project.
• Assembly of small volumes of prototype accessories for design proving and V&V activities.
• Drafting and refinement of manufacturing instructions, jigs, tools and procedures for the product.
• Attendance at pre-clinical trials, along with drafting and agreement
• of the necessary trials protocols and records.
• Drive continuous improvement as part of Creo’s Quality Management System.
• Project Management activities for an endoscopic electro-surgical project.

What we are looking for

• Excellent project & organisational skills
• Excellent communication skills both verbally and orally
• Experience of working in a highly technical engineering environment
• First-class engineering standards gained in highly technical environments
• Excellent engineering and root cause analysis problems solving skills (demonstrable use of the full range of problem-solving tools) with an ability to troubleshoot mechanical, electrical and electronic designs.
• Highly experienced working within a Quality Management System such as ISO9001 or ISO134385.
• An ability to multi-task and work under pressure to meet tight deadlines..
• To undertake any other duties which may be required, and which are commensurate with the post’s position within the company.
• Able to travel domestically and internationally as and when required.
• Must have the unrestricted right to work in the UK.

Education and professional qualifications required:

• Degree qualified or equivalent skills from a mechanical, electronic, or product engineering-based discipline.

What we can offer:

• A flexible, inspiring, and fun work environment. We thrive as a ‘can-do’ and empowered culture
• Our time and investment for your development, to achieve your goals
• Competitive salary and perks
• The opportunity to be part of, develop, explore, and discover technology that aims to improve the lives of many

About us

Creo Medical is a growing company with a focus on improving patient outcomes by applying Advanced Energy to the emerging field of therapeutic endoscopy. We utilise patented technology to deliver microwave and bipolar radiofrequency energy via our CROMA Advanced Energy platform, enabling a wide range of miniature endoscopic devices with precise resection, dissection, hemostasis, and ablation capability to treat as many conditions as possible.

Anything is possible with the right approach

As a talented team with diverse backgrounds, we have a depth of expertise across all areas of the business. We succeed by applying our ‘can-do’ attitude to innovate so that we can satisfy our hunger for solutions.

Engagement and collaboration are key to our business success and to continually innovate and exchange ideas and knowledge in an open, encouraging, and developmental environment whilst we challenge the status quo.

Being part of our team will mean making a real difference globally

With a passion for improving healthcare, our products are used to treat patients in multiple countries and so we continue to expand our team to introduce different experience into the design, manufacture, production, and commercialisation of electrosurgical medical devices, ultimately impacting and being part of an extraordinary journey.