NPI Engineer

Prospero Engineering
From £30,000 to £45,000 per annum
27 Sep 2016
20 Oct 2016
Contract Type
Prospero Engineering have a fantastic new opportunity for an NPI Engineer to join a hugely successful and rapidly growing Technology Company in Warickshire Overview · Support the NPI process from Engineering into Manufacturing ensuring 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 Key Responsibilities ·D evelop the manufacturing assembly process of a complex programmable electrical 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 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) Requirements/Qualifications · Mechanical/Manufacturing Engineer (HND/Degree) with manufacturing engineering experience · Preferably experienced with 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 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 Please note, all applicants must be eligible to live and work in the UK. This job was originally posted as