For over 25 years, Surgical Innovations has proudly designed, developed and manufactured high quality, precision engineered instruments from our Head Office in Leeds. SI are a leading UK manufacturer of medical devices for minimally invasive surgery.
As the main trading arm of Surgical Innovations Group Plc., which is listed on the Alternative Investment Market (AIM), we currently employ over 60 staff in our 32,000 sq.ft. space. Which houses an extensive machine shop, two clean rooms, injection moulding, warehousing and office space.
SI is also proud to work with other leading medical device companies on an OEM basis to design and manufacture medical devices bespoke to their needs. We have also transferred our technologies, which are designed to access small spaces with ultimate precision, into the industrial market.
Key to our success is our team of employees. We place great value on our mutually respective relationships with employees, and seek to identify, nurture and retain talent. We offer a competitive benefits package, continuous training and development opportunities.
We are looking for talented people who share our vision and to join our team. Please see below for any jobs we currently have available.
We are always looking for new talent, if you think you have what we’re looking for, please contact: si@surginno.co.uk
Available Roles
Design & Development Engineer
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Job Title: Design & Development Engineer
Department: R&D
Reports To: R&D Manager
General Overview of the Role
Design & Development Engineer within a medical device company specialising in the design and manufacture of innovative surgical products for Minimally Invasive Surgery (MIS). User-cantered product design which meets clinical needs is at the heart of the business. The company is required to comply with ISO 13485, the Medical Device Directive and FDA Medical Device Quality System Regulations (QSR) for FDA 21 CFR Part 820 compliance.
Duties and Responsibilities
- Design and development of innovative medical products from concept through to production.
- Meet product usability requirements through direct feedback loops with customers, surgeons and healthcare personnel.
- Compilation and up-keep of detailed Design History Files (DHF) for a product and submitting Technical Files for CE submission while following internal Standard Operating Procedures.
- Definition and execution of product V&V testing including but not limited to mechanical/functional, electrical, biocompatibility, cleaning / sterilisation and packaging to ensure design inputs are met.
- Component and assembly drawings / CAD modelling using Pro-Engineer Creo software.
- Design support to existing product lines - drawings, product routings, inspection and process improvement.
- Execute Design for Assembly (DFA) and Design for Manufacturing (DFM) assessment on project components and assemblies.
- Participate in FMEAs & risk assessments in accordance with ISO 14971.
- Develop and utilize project functional specifications, timelines for engineering tasks and DFMEA's for components and assemblies.
- Investigate and revise design patent opportunities and infringements.
- Perform tolerance analysis on components and assemblies for projects.
- Demonstrate regular use and application of solid engineering principles, theories, concepts and techniques.
- Project Management - Developing and maintaining a detailed project plan and delivering in accordance with the plan.
- Develop robust manufacturing and assembly processes with clearly documented operator instructions. Design and introduce fixtures & jigs for manufacture and assembly.
- A good working knowledge of manufacturing processes, materials and assembly techniques – particularly CNC machining and injection moulding.
- Implement cost reduction initiatives while maintaining high quality standards.
- Investigate problems, analyse root causes and derive corrective actions in relation to Non-conformances.
Any other duties as assigned by Management
Skills/Experience
- Worked within a regulated industry
- Understands and can get involved in all aspects of product design & development
- Experience of ISO 14971
- Proficient in Pro-Engineer Creo software
- Knowledge of CNC machining and injection moulding
Education
- Must be educated to degree level in product design or mechanical engineering (or equivalent qualification).
If you would like to find out more about this role, please forward questions along with your CV to stephanie.smith@surginno.co.uk
NO AGENCIES PLEASE
Production Engineer
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Job Title: Production Engineer
Department: Production
Reports To: Production Manager
General Overview of the Role
The role works alongside the Manufacturing, Quality and Design functions of the business and offers a unique opportunity to implement innovative initiatives to help improve production efficiencies and introduce new products to market.
Duties and Responsibilities
- Produce detailed MVP, PFMEAs & participate in risk assessment activities in accordance with ISO 14971.
- The validation of manufacturing processes including IQ, OQ and PQ protocols and reports.
- Project management – Ensure NPI projects are transferred into manufacturing on time and to budget.
- Adhere to good documentation practice and actively contribute to maintaining Technical Files, Design History Files (DHRs) and Device Master Records (DMRs).
- Produce DWGs to BS8888 standard.
- 3D CAD modelling and DWG using Pro Engineer/Creo 2
- Run detailed mechanical test programs and produce fully auditable technical reports.
- Assisting with the implementation of corrective actions following customer complaints and both internal and external NCR’s.
- Constantly reviewing efficiency or cost saving opportunities.
- Support idea generation by defying new processes, problem resolution activities and technology introduction to improve both existing products and aid with new products.
Any other duties as assigned by Management
Skills/Experience
- Must have a professional attitude and flexible approach to working.
- Be efficient with great attention to detail and commercial awareness of project deadlines.
- The ability to create drawings and CAD files and understanding of component/device modelling along with the understanding of CNC machine/Mould machine programming.
- Proficient knowledge of jig & fixture design and manufacturing.
- Strong experience of measurement/inspection activities, including GR&R and CMM programming/set up.
- Previous in-depth experience of process validation activities and associated documentation.
Minimum of a bachelor’s degree required, preferably in a Science or Engineering field.
Experience in a Medical Device environment.
Education
Degree or Equivalent in Engineering
Desirable Skills/Education
Medical precision manufacturing background with experience of Injection moulding and machined components.
NO AGENCIES PLEASE
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