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Npi Manufacturing Engineer

4 weeks ago

Galway, Galway, Ireland Wallace Myers International Full time

Manufacturing NPI (New Product Introduction) Engineer
An exciting opportunity has arisen for a
Manufacturing NPI Engineer
to support operations as products transition from pilot production to commercial launch.
Responsibilities
Execute equipment, process, and test method validations.
Support manufacturing processes, identify risks, and implement mitigations to improve yield and efficiency.
Track and drive New Product Introduction activities ahead of commercialisation.
Collaborate with equipment vendors to identify and deliver process improvements.
Foster a strong problem-solving culture using DMAIC, Six Sigma, and other standard methodologies.
Develop and manage process development plans with a focus on budget, risk, and timelines.
Partner with R&D to align production with development programs, materials, processes, and equipment improvement projects.
Create and maintain master validation plans for line equipment.
Ensure equipment maintenance and calibration are completed on schedule.
Execute IQ/OQs for lab and production equipment.
Apply project management methodologies to communicate and track activities.
Background & Qualifications
Bachelor's degree in Mechanical, Manufacturing, Chemical, Biomedical Engineering, or related discipline.
Minimum 2 years' experience in a manufacturing or process development role within the medical device sector.
Hands-on experience with new equipment introduction (IQ/OQ), process characterisation, and validation.
Knowledge of test method validation and processes such as lyophilisation.
Strong understanding of GDP & GMP standards.
Excellent knowledge of engineering materials used in medical device manufacture (hydrogels, metals, polymers).
Skilled problem solver with experience in DMAIC or similar tools.
Highly organised, innovative, and able to work independently or as part of a team.
Comfortable with hands-on technical work.
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See our website for more details.
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