NPI Manufacturing Engineer

1 day 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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