A growing medical device client in Galway are seeking an Operations Manager within Process Development to play a pivotal role in advancing and scaling its Class III product portfolio. This position will lead process development and operational readiness, supporting pilot manufacturing and future commercialisation.
Key Responsibilities:
- Lead end-to-end process development from clinical stage through scale-up to commercial readiness
- Oversee and optimise pilot production lines, partnering with external manufacturing providers
- Drive operational excellence and continuous improvement across engineering and manufacturing activities
- Collaborate closely with R&D to ensure effective transfer from development into manufacturing (NPI)
- Develop scalable, compliant processes aligned with regulatory standards (FDA, ISO 13485)
- Lead, mentor, and grow a high-performing team
- Contribute to strategic planning for manufacturing scale-up and long-term operations
Key Requirements:
- Minimum 10 years’ experience in the medical device industry (essential), ideally with Class III products specifically catheter based medical devices.
- Strong background across manufacturing, operations and process development in regulated environments
- Proven experience supporting products from clinical stage through scale-up
- Demonstrated expertise in process optimisation and new product introduction
- Prior people management and leadership experience
- Experience working within or alongside multinational organisations highly desirable
- Strong technical, analytical and cross-functional leadership capabilities
For more information and a confidential discussion on the role please contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091 706718
