Manufacturing Engineer, Medical Devices | NPI & Transfer
HERO Recruitment
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Job summary
HERO Recruitment in Galway City seeks a Manufacturing Engineer to support the introduction and transfer of innovative medical technologies into full-scale commercial manufacturing. You will establish robust, compliant production processes and lead validation activities in a hands-on, regulated environment.
Key responsibilities include leading NPI/product transfer projects, establishing repeatable process controls, driving CI-based improvements, and ensuring adherence to GMP, regulatory, quality,
Qualifications
- Degree in engineering or equivalent technical discipline.
- 3–5+ years in Manufacturing Engineering within medical device or regulated healthcare manufacturing.
- Experience supporting NPI, product transfer, or scale-up activities.
- Strong validation experience (IQ/OQ/PQ) and knowledge of ISO standards.
Responsibilities
- Lead engineering activities within NPI and product transfer projects.
- Establish robust, repeatable manufacturing process controls.
- Drive process optimisation using structured CI methodologies.
- Ensure GMP, regulatory, quality, and EHS standards compliance.
- Lead equipment and process validations (IQ, OQ, PQ).
- Investigate and resolve non-conformances and contribute to risk assessments.
Skills
Education
Job description
HERO Recruitment in Galway City seeks a Manufacturing Engineer to support the introduction and transfer of innovative medical technologies into full-scale commercial manufacturing. You will establish robust, compliant production processes and lead validation activities in a hands-on, regulated environment.
Key responsibilities include leading NPI/product transfer projects, establishing repeatable process controls, driving CI-based improvements, and ensuring adherence to GMP, regulatory, quality,
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