NPI Engineer - County Roscommon, Ireland - Cpl

Description

NPI Engineer

My client, a global partner for the design, development and manufacture of medical devices, are looking to hire a NPI Engineer on a permanent basis.

This role will suit someone coming from a regulated manufacturing environment and capable of overseeing the planning and co-ordinating New Product Design

This is a permanent onsite role, based in Carrick-on-Shannon,

Responsibilities

• Planning, implementing and co-ordination of New Product Introductions to include product design, product specifications, process validations identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement in accordance with Procedures and Regulatory standards.
• Ensure the requirements of ISO 13485, ISO 45001, ISO 14001 and ISO 50001 are considered during design, development and new product introduction and integrated into production processes.
• Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design history Files in accordance with Procedures and Regulatory Standards.
• Sourcing and implementing tooling, equipment and technologies, as required to make new and existing production.
• Co-Ordinating the supply of extrusions, if required, with the Extrusion department including agreeing specifications of tubing, resins and quality requirements.
• Planning and implementing manufacturing cell lay-outs, workstation design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets.

Requirements

• Third level engineering qualification in Polymer, Biomedical, Mechanical, Design; Minimum Bachelor's Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent)
• 2-3 years' experience in new product introduction, manufacturing, quality or process engineering, preferably in catheter manufacturing.
• Experience in Project Management regarding new product introduction, preferably in a Medical Device environment.
• Manufacturing processes used for manufacturing catheters, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.

For more information, please contact

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