NPI / Product Transfer Engineer
Location: Galway
Schedule: Full-time, weekdays
A leading Galway-based medical device manufacturer is seeking an experienced NPI / Product Transfer Manufacturing Engineer to join its expanding Engineering team. This is a newly created role within a core engineering group, focused on supporting the successful introduction and transfer of innovative medical technologies into full-scale commercial manufacturing. The successful candidate will play a key role in establishing robust, efficient, and compliant production processes, working cross-functionally to ensure a smooth transition from development through to commercialisation. This hands‑on engineering role requires strong technical capability, structured problem‑solving skills, and experience in validation within a regulated manufacturing environment.
Key Responsibilities
Support and lead assigned engineering activities within NPI and product transfer projects.
Establish robust and repeatable manufacturing process controls.
Drive process optimisation and performance improvements using structured CI methodologies.
Apply scientific and data‑driven problem‑solving approaches to improve yield and efficiency.
Ensure compliance with GMP, regulatory, quality, and EHS standards.
Collaborate with automation and technical teams to develop stable and capable processes.
Support new technology introductions and effective engineering change management.
Lead and execute equipment and process validations (IQ, OQ, PQ).
Investigate and resolve non‑conformances in line with quality systems.
Contribute to risk assessments (process, equipment, and product).
Develop technical expertise across core manufacturing technologies.
Key Requirements
Level 8 Honours Degree in Engineering (or equivalent technical discipline).
3–5+ years’ experience in a Manufacturing Engineering role within medical device or regulated healthcare manufacturing.
Proven experience supporting NPI, product transfer, or scale‑up activities.
Strong validation experience (IQ/OQ/PQ).
Experience implementing continuous improvement initiatives.
Knowledge of regulatory and quality requirements in a regulated environment (e.g., ISO standards).
Strong documentation and technical report writing skills.
Proficiency in CAD is advantageous.
For further information on this role, please contact Gavin Moran on 087 4108620 or via email at connect@hero.ie.
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