We are supporting our Galway based medical device client who are hiring a Manufacturing Engineer to join their core Engineering team. In this role, you will play a vital part in ensuring the efficient and high-quality manufacture of medical devices. Using your technical expertise, problem-solving skills, and validation experience, you will help optimize manufacturing processes, support new product introductions, and drive continuous improvement.
Key Responsibilities:
1. Lead and execute tasks within projects, ensuring successful outcomes.
2. Implement process controls to ensure robust and repeatable manufacturing.
3. Drive continuous improvement initiatives to maximize process performance.
4. Apply scientific and analytical approaches to problem-solving and process optimization.
5. Ensure all engineering work complies with regulatory, quality, and safety standards.
6. Collaborate with Automation Engineering to develop stable, capable new processes.
7. Provide technical support for new products, technologies, and process changes.
8. Evaluate and correct non-conforming products or processes.
9. Complete validations and process improvements using statistical tools and Six Sigma techniques.
10. Support the development of in-house subject matter expertise across core technologies.
11. Participate in process, equipment, and health & safety risk assessments.
12. Provide progress updates to senior management and support routine manufacturing meetings.
13. Maintain and report key manufacturing metrics on a weekly basis.
Qualifications:
14. Bachelor's or Master's degree in Engineering (or equivalent).
15. 3–5 years' experience in a Manufacturing Engineering role within the medical device or healthcare industry.
Skills & Experience:
16. Experience with balloon forming is ideal but not required.
17. Proven success in implementing continuous improvement initiatives.
18. Proficiency in CAD software.
19. Strong report writing, documentation skills, and attention to detail.
20. Knowledge of regulatory requirements, quality standards, and GMP practices.
21. Experience with validation and qualification (IQ, OQ, PQ) of equipment and processes.