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!
Requirements:
- 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.
Responsibilities:
- 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.
emer@emtechrecruitment.ie
