Process Development and Operations Manager

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.

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• 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
  

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• 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

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• 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