|Job Ref:||204406853||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||Warwickshire||City:||Warwickshire||Address:||Post Code:||B49||Salary:||£35000 - £45000/annum plus benefits||Post Date:||07/10/2016 02:08|
Manufacturing Engineer (Medical Devices, Plastic Mouldings, Assembly)|
£45k + benefits
This is a fantastic opportunity to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion dollar global market. The company now requires an experienced Manufacturing NPI Engineer (Consumables) with responsibility to:
• Support the NPI process from Engineering into Manufacturing for the Consumable products to ensure all manufacturing processes and equipment are fully qualified/validated prior to release.
• Facilitate the design, validation and deployment of automated assembly equipment and related procedures
• Support the Change Management Process for Manufacturing
• Implement Lean Manufacturing practices
• Working with the Contract Manufacturing Organisation to develop the manufacturing assembly processes for the Consumable products of a complex medical device from existing Technical Product Documentation and Work Instructions.
• Ensure all manufacturing processes and methods are in place and fully qualified/validated prior to release.
• Develop a build manual sufficient to describe the assembly process to achieve repeatable production.
• Develop device history records to improve traceability, repeatability and quality control.
• Identify and implement yield improvement and design for manufacture opportunities in collaboration with the Engineering and Operations teams to improve manufacturability and reliability and reduce cost.
• Ownership of midline tests, determine where testing is required, develop test specifications and collaborate in test equipment production.
• Support NPI builds and corresponding design verification and validation activities
• Support qualification and validation of equipment and processes including protocols and reports.
• Development of calibration and maintenance processes and schedules of line equipment as needed
• Drive the design transfer process for consumables to achieve project deadlines, ensuring the design is sufficiently defined to provide information to the CMO and the manufacturing processes are sufficiently defined and validated to facilitate release.
• Own PFMEA for consumable products and support DFMEA activities
• Support troubleshooting of device failures and utilise tools to enable fault finding.
• Satisfy Quality & Regulatory needs of manufacturing process documentation and appropriate degree of control.
• Coordinate with Manufacturing team to establish and monitor KPIs (FTY, cost analysis, Pareto analysis of failures, SPC data and non-conforming material)
• Mechanical/Manufacturing Engineer (HND/Degree) with manufacturing engineering experience
• Preferably experienced with Class 11 & 111 medical devices, ideally moulded components
• Working knowledge of BS EN ISO 13485, BS EN ISO 14971, BS EN ISO 60601 and FDA QSR processes
• Experience of batch and volume moulded component manufacturing and assembly techniques.
• Experience of specifying manufacturing assembly fixtures.
• Quality focus, able to identify appropriate controls and implement document/process solutions e.g., process flow, PFMEA, control plans and support development of work instructions.
• Knowledge of relevant manufacturing assembly processes; injection moulding, inspection, assembly, adjust, test, record.
• Knowledge of 3D CAD (ideally SolidWorks) so as to be able to interrogate drawings and assemblies, create and manipulate exploded diagrams etc.
• Implementation of lean and six sigma practices