|Location: Leeds, West Yorkshire||Salary: £35000 - £40000 per annum|
|Sector: Medical Devices||Type: Permanent|
|Contact: Matt Henocq||Job Published: 17 days ago|
Design & Development Engineer
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.
- 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
Skills and 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
Services advertised by Gold Group are those of an Agency and/or an Employment Business.