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
#J-18808-Ljbffr