Manufacturing Project Engineer required by market-leading medical devices company in Galway city to support the initial design stage gates while taking the lead to deliver the final stage gates. Working in collaboration with R&D and Commercial teams, you will contribute to the delivery of strategic growth plans through the advancement of the current and future Product technologies.  You will challenge and improve Manufacturing systems!


  • Level 8 qualification in Engineering, Technology or Science with minimum 2 years’ experience OR Level 7 qualification in Engineering, Technology or Science along with a Trade certificate and minimum 8 years’ experience.
  • Experience in Process characterization, Validation and statistical methods.
  • Meticulous attention to detail with a methodical and analytical approach to problem solving.
  • Flexibility to travel to vendor sites to support service and project activities.
  • Must be able to work in a dynamic environment with little supervision or daily direction.
  • Excellent interpersonal skills with demonstrated decision-making competencies.
  • Very strong organizational, Project Management and communication skills.
    Microsoft Package skills – MS Word, Excel, Project etc.


  • Plans, organizes and delivers direction and support to Engineers and project teams across a diverse range of projects.
  • Full Implementation and support to team Individual Development Plans
  • Lead NPD Manufacturing project tasks from product initial concept to Release to Sales to deliver Patient focused Product enhancements.
  • Early design stage task support will include working with R&D, Quality Engineering and the Supply Chain teams on supplier selection, required
  • Risk documentation (e.g., PFMECA) and qualification plans.
  • Ensure prioritisation of strategic projects and KPIs.
  • Completing product and process changes through process efficiency, change control and documentation updates.
  • Later design stage gate support, collaborating with Regulatory, Commercial and Production to prepare for Regulatory registration and release to sales through coordination of BOMs, Finished Good Labelling and Manufacturing documentation.
  • Project Troubleshooting with cross-functional teams including Quality Engineering, Supply Chain, Manufacturing and R&D.
  • Ensure Engineering compliance with relevant International Standards.
  • Identification of product/process improvement opportunities through design stage gate review activities.
  • Evaluate proposed equipment/processes/components changes about the impact on product quality, safety, stability, performance, or waste technology.
  • Support all customer, FDA, and Regulatory audits.

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