Senior Manufacturing Project Engineer required by market-leading medical devices company in Galway city
You will lead a team that will collaborate with R&D, Quality Engineering and Commercial teams to deliver strategic growth plans through advancing current and future Product technologies.
The role will support the initial design stage gate reviews while taking the lead to deliver the final stage gate review procedure. In all cases, the role is expected to challenge and improve NPD Manufacturing systems as enablers to advance project execution.
- Level 7 Degree/Diploma qualification in Engineering, Technology or Science with a Trade certificate and a minimum of 15 years of relevant experience OR Level 8 Degree qualification in Engineering, Technology or Science with a minimum of 8 years of relevant experience.
- People management experience required and a proven track record of mentoring engineers in a collaborative working environment.
- Excellent understanding of EN ISO 13485, MDSAP and FDA requirements as these apply to this role.
- Meticulous attention to detail with a methodical and analytical approach to problem solving.
- 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
- Project-Manage cross-functional teams delivering on the expansion of the product portfolio across the globe while building Manufacturing Engineering capacity and reliability to meet demand.
- 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.
- Support all customer, FDA, and Regulatory audits.