NPI Manufacturing Engineer
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NPI Manufacturing Engineer
New Product Introduction (NPI) Engineer - £45000 - Stratford - Upon Avon - Alcaster
Job DescriptionNew Product Introduction (NPI) Engineer - £45000 - Stratford - Upon Avon - Alcaster
A leading medical company is currently recruiting for an New Product Introduction (NPI) Engineer to join the team in Alcaster. A the New Product Introduction (NPI) Engineer you will support the NPI process from Engineering into Manufacturing to ensure all manufacturing processes and equipment are fully qualified/validated prior to release.
You responsibilities will include:
. 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.
The successful New Product Introduction (NPI) Engineer will have the following:
. 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
To apply for this position please select "APPLY NOW" or follow the instructions below to send your CV and cover letter to Amanda Humble at Advanced Resource Manager 02392228232
Advanced Resource Managers Engineering Limited operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.