Job Details
NPI Engineer
- ID
- 15389
- Location
- Galway City
- Role Type
- Permanent
- Contact
- Gavin Moran
NPI Engineer
NPI Engineer
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 is a hands-on engineering role requiring strong technical capability, structured problem-solving skills, and experience in validation within a regulated manufacturing environment.
Main 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 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.
- 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 (e.g. ISO standards).
- Strong documentation and technical report writing skills.
- Proficiency in CAD is advantageous.
For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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