À propos
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.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
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
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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
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Compétences linguistiques
- English
Avis aux utilisateurs
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