We are supporting our client as they look to hire a Senior Manufacturing Engineer for their Manufacturing Facility in Galway. This is an integral hire for the team as they expand their business into new projects.
Main Duties
1. Lead the development, optimization, and validation of manufacturing processes.
2. Drive NPI and ensure smooth product transfers into production.
3. Implement process validation (IQ, OQ, PQ) to meet ISO 13485 and customer requirements.
4. Collaborate with teams to refine machining processes and improve results using innovative solutions.
5. Use SPC tools (., Minitab) for process monitoring and improvement.
6. Apply DFMA principles to optimize manufacturing and reduce costs.
7. Lead process improvements and troubleshooting in a regulated environment.
8. Use root cause analysis (8D, DMAIC, FMEA) to solve process inefficiencies and quality issues.
9. Implement Lean, Six Sigma, Kaizen, and OEE methodologies to drive improvements.
10. Mentor junior engineers and foster a culture of innovation and continuous improvement.
Requirements
11. 7+ years of experience in manufacturing engineering, preferably in the medical device industry.
12. Expertise in process validation (IQ, OQ, PQ), SPC, and Lean Six Sigma.
13. Understanding of CNC machining, precision manufacturing, metrology, and automation desirable.
14. Knowledge of GD&T, CAD (SolidWorks, AutoCAD), and ISO 13485.
15. Leadership experience with cross-functional teams.
Desirable
16. Bachelor's degree in Mechanical, Manufacturing, Biomedical, or related field.
17. Lean Six Sigma certification (Green/Black Belt) is a plus.