Our client, a rapidly growing medical device company based in Galway are seeking an experienced Manufacturing Engineer to play a key role in shaping their manufacturing strategy and driving process improvements as they scale up operations.
Responsibilities:
1. Provide technical support to manufacturing operations to ensure consistent product quality, efficiency, and compliance with regulatory standards.
2. Lead process improvements using Lean and Six Sigma methodologies to reduce cost, improve yield, and increase throughput.
3. Support the introduction of new products and technologies into production, including process design, equipment selection, and validation (IQ/OQ/PQ).
4. Collaborate with cross-functional teams (Quality, R&D, Maintenance, Supply Chain) to resolve process and equipment issues.
5. Develop and maintain manufacturing documentation, including work instructions, process flow diagrams, and validation reports.
6. Lead root cause investigations and implement effective corrective and preventive actions (CAPA).
7. Support and drive continuous improvement initiatives using data-driven decision making and problem-solving tools (DOE, FMEA, SPC).
8. Ensure compliance with ISO 13485, FDA, and other relevant regulatory standards.
9. Provide training and technical guidance to operators and technicians on new or revised processes and equipment.
10. Participate in equipment upgrades, capacity expansion, and automation projects.
Qualifications and Experience:
11. Bachelor's Degree in Mechanical, Manufacturing, Biomedical, or Industrial Engineering (or equivalent).
12. 3+ years of experience in a manufacturing engineering role, ideally within the medical device or pharmaceutical industry.
13. Strong understanding of GMP, ISO 13485, and FDA regulatory requirements.
14. Proven experience with process validation (IQ/OQ/PQ), equipment qualification, and risk management.
15. Demonstrated ability to apply Lean Manufacturing and Six Sigma principles to process improvement.
16. Excellent problem-solving, analytical, and communication skills.
17. Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.