Operations Manager - Process Development

A growing medical device client in Galway are seeking a Senior Process Development & Operations Manager 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
• 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