|Job Ref:||204776276||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 pension & bonus||Post Date:||12/10/2016 03:56|
Manufacturing Engineer (Assembly, Test, Medical Devices)|
£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 New Product Introduction (NPI) Engineer (Machine) with responsibility to:
• Support the NPI process from Engineering into Manufacturing for the product to ensure all manufacturing processes and equipment are fully qualified/validated prior to release.
• Facilitate the design and deployment of midline and end of line test procedures and equipment
• Contribute to the development and maintenance of the product service & repair manual
• Support the Change Management Process for Manufacturing
• Implement Lean Manufacturing practices
• Working with the Contract Manufacturing Organisation to develop the manufacturing assembly process of a complex programmable electrical 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 the device 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 machine and support DFMEA activities
• Collaborate with the Engineering and Service team to develop a service strategy and service & repair manual incorporating planned preventative maintenance based on analysis of component specifications and real reliability data.
• Support troubleshooting of device failures and create tools to enable fault finding by service teams either at central servicing centres or potentially in the field (at point of installation).
• 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 complex programmable electromechanical devices including pneumatics, fluidics, and control systems.
• Experience of batch and volume manufacturing and assembly techniques including interim and end of line test specification and development for medical devices distributed globally
• Experience of specifying manufacturing assembly fixtures.
• Working knowledge of BS EN ISO 13485, BS EN ISO 14971, BS EN ISO 60601 and FDA QSR processes
• 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; 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