Are you an experienced Manufacturing Engineer looking to play a pivotal role in the production of life-saving technologies?
We're proud to be partnering with a leading organisation in the medical device sector to recruit a Manufacturing Engineer for their expanding Galway site. This role offers an exciting opportunity to work in a highly regulated, innovation-driven environment where your ideas will directly contribute to patient safety and product quality.
Join a company that's revolutionising medical technology and play a key part in scaling cleanroom production, supporting NPI projects, and driving process improvements.
Key Responsibilities
1. Support and improve cleanroom manufacturing processes in line with quality, cost, and delivery goals.
2. Lead and contribute to New Product Introduction (NPI) initiatives from concept to commercialisation.
3. Implement continuous improvement strategies to optimise efficiency, reduce waste, and enhance process reliability.
4. Prepare and execute validation protocols (IQ/OQ/PQ) and support equipment qualification activities.
5. Develop and maintain process documentation including work instructions, FMEAs, and process flow diagrams.
6. Investigate non-conformances and implement CAPAs to ensure product and process compliance.
7. Collaborate cross-functionally with Quality, R&D, and Production teams to meet project timelines.
8. Ensure all activities are compliant with GMP, ISO 13485, and regulatory standards.
Candidate Requirements
9. Degree in Engineering, Manufacturing, Biomedical, Mechanical, or a related discipline.
10. Minimum 2 years' experience in a regulated manufacturing environment, ideally medical devices.
11. Strong knowledge of GMP, process validation, and manufacturing best practices.
12. Demonstrated experience in problem-solving tools (., 5 Whys, Fishbone, FMEA).
13. Excellent communication and cross-functional collaboration skills.
For more details on this role, feel free to reach out to Emma Cawley at. Kindly note that, given the expected high volume of applications, we can only respond to candidates whose qualifications closely match the specific requirements of the role. We genuinely value your interest in this opportunity and thank you for your understanding.