An innovative and rapidly growing medical device manufacturer is seeking a Manufacturing Engineer to join its core engineering team in Galway to act as an SME for an upcoming Product Transfer. This role will play a key part in supporting the transfer of new products into manufacturing and the establishment of robust, scalable production processes.
Key Responsibilities
- Support the transfer of new products and technologies into manufacturing.
- Develop and implement robust manufacturing processes and process controls.
- Drive continuous improvement initiatives to optimise production performance.
- Support process development and automation integration for new manufacturing processes.
- Lead or support process and equipment validation activities (IQ, OQ, PQ).
- Troubleshoot manufacturing issues using structured, data-driven problem-solving methods.
- Ensure compliance with quality, regulatory and health & safety standards.
- Support risk assessments for processes, equipment and product safety.
- Provide technical input on non-conformances, process improvements and change management.
- Contribute to engineering metrics, reporting and cross-functional manufacturing meetings.
Requirements
- Level 8 Degree in Engineering or related discipline.
- 3–5 years’ Manufacturing Engineering experience within the medical device or healthcare sector.
- Experience with process validation, process development and manufacturing scale-up.
- Proven track record in continuous improvement and problem solving.
- Strong technical documentation and reporting skills.
Desirable
- Experience with catheter-based device manufacturing (e.g. thrombectomy or atherectomy).
- Exposure to laser welding or precision metal processes.
- Familiarity with CAD software and statistical analysis tools.
For more information and a confidential discussion on the role please contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091 706718
