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NPI Engineer

Exciting opportunity for an NPI/Pilot Engineer with a leading life sciences/med device company based in Cork on a fixed-term contract (12 months) with great scope for permanency.

Position responsibilities:

  • Engineering lead for new products and line extensions for Cork Manufacturing Operations, Project Management lead depending on project responsibilities, scope and complexity

  • Provides Manufacturing support for new R&D products from Concept to Production (Product Development Procedure), is an active team member who contributes to the development of new concepts, processes and products. Co-ordinates inputs from Cork Manufacturing for Preliminary Investigation, Detailed Investigation, Product Development & Validation

  • Ensures new processes are designed for manufacture, automated, innovative, cost-effective and meet all Quality and EHS regulatory requirements

  • Prepares Manufacturing product cost estimates under guidance

  • Initiates equipment and mould User Requirement Specifications, vendor selection, requests for quotation and equipment/ mould build, management of same depends on project responsibilities, scope and complexity

  • Manages and executes the production equipment transfer into Cork, takes a hands-on lead role in activities required to achieve Commercialization

    • Installation – executes IQ & OQ

    • Completes training – Engineers, technicians and operators

    • Documentation – drafts and executes validation protocols under guidance from QA, SOPs etc.

    • Trouble shooting & problem solving

    • Demonstrates Manufacturability

    • Executes PQ under guidance from QA

  • Supports Pilot production, process optimization, scale up production and handover to production

  • Prepares and manages the Manufacturing budgets associated with each project

Key Requirments:

  • Engineering Degree – Level 8

  • Minimum 3 – 5 years engineering experience in Manufacturing, Moulding, New Product Introduction or Product Development. Medical Device and over-moulding experience is a plus

  • Self starter, hands on, innovative, ability to influence

  • Strong problem-solving skills, ability to assess and identify root cause

  • Proven project management experience, ability to plan and execute

  • Working knowledge & experience of Lean, 6 sigma, SPC, FMEA, DOE, Quality & validation systems, Project management tools

For a confidential discussion and more information on the role, please contact Barry O'Brien  

barry.obrien@collinsmcnicholas.ie

021-4911060