About the role

This is an exciting opportunity to join our growing Operations team. The right candidate will provide process engineering skills and expertise by planning, analysing, and implementing process improvements to departmental objectives.

In addition to this role requires investigative skills to identify root causes, problem solving and provide innovative solutions in line with the regulatory requirements and controls. Enabling growth and expansion of the manufacturing facilities and increased production capacity.

The selected candidate will be required to generate documentation for continued compliance with 21 CFR Part 820 & ISO 13485.

Key responsibilities

• Develop processes for the manufacturing of medical products containing small parts at low to medium volume.
• Implement GMP (Good Manufacturing Practices) throughout manufacturing.
• Perform qualifications including IQ/OQ/PQ of jigs and fixtures.
• Provide design improvements to ensure continued compliance of products within the manufacturing remit
• Identify process problems and non-conformance’s in manufacturing processes and develop corrective and preventative actions.
• Define and perform maintenance and calibration procedures.
• Drive continuous and process improvements.
• Coordinate the training of Manufacturing Operators and act as a mentor and technical resource.
• Development of manufacturing jigs and fixtures, with the intent of enabling poke yoke design where possible.
• Generation of documentation in line with 21 CFR Part 820 & ISO 13485 requirements to ensure all work is recorded.
• Review procedures for accuracy and make updates using a Document Change Order procedure to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings.
• Support all audits and work under ISO13485.
• Manage change, to ensure the impact of design and process changes are fully assessed and necessary revisions to the technical file are made using engineering change control procedures.

What we are looking for

• First class engineering standards.
• Excellent engineering and root cause analysis problems solving skills (demonstrable use of the full range of problem-solving tools) with an ability to trouble shoot mechanical, electrical and electronics designs, carry out failure mode analysis and support mechanical design changes.
• Excellent product and process validation and verification expertise including IQ/OQ/PQ DOE and TMQs.
• Statistical analysis (preferably experienced with use of Minitab).
• Thorough understanding of MVP, PFMEA, Manufacturing plan, manufacturing process flow.
• Excellent abilities with CAD, specifically Solidworks.
• Experience of designing products and performing verification to meet IEC60601 test standards.
• Highly experienced working within a Quality Management System ISO13485.
• An ability to multi-task and work under pressure to meet tight deadlines.
• Experience in relevant assembly technologies:
• Adhesives dispensing and curing
• Laser and resistance welding skills
• Induction solder experience
• Advanced soldering skills
• PLC control experience
• Crimping and mechanical joint experience
• Experience of equipment specification and management of external vendors
• Experience with DFM/A and DFT
• Must have unrestricted Right to Work in the UK

Qualifications: 

• Degree qualified or equivalent skills from a mechanical, electronic, manufacturing, 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.