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.