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Manufacturing Engineer

  • Division: Engineering
  • Contact Email: emma.barry@collinsmcnicholas.ie
  • Job Ref: 24951

Our client, a rapidly growing medical device company based in Galway are seeking an experienced Manufacturing Engineer to play a key role in shaping their manufacturing strategy and driving process improvements as they scale up operations.

Responsibilities:

  • Provide technical support to manufacturing operations to ensure consistent product quality, efficiency, and compliance with regulatory standards.
  • Lead process improvements using Lean and Six Sigma methodologies to reduce cost, improve yield, and increase throughput.
  • Support the introduction of new products and technologies into production, including process design, equipment selection, and validation (IQ/OQ/PQ).
  • Collaborate with cross-functional teams (Quality, R&D, Maintenance, Supply Chain) to resolve process and equipment issues.
  • Develop and maintain manufacturing documentation, including work instructions, process flow diagrams, and validation reports.
  • Lead root cause investigations and implement effective corrective and preventive actions (CAPA).
  • Support and drive continuous improvement initiatives using data-driven decision making and problem-solving tools (DOE, FMEA, SPC).
  • Ensure compliance with ISO 13485, FDA, and other relevant regulatory standards.
  • Provide training and technical guidance to operators and technicians on new or revised processes and equipment.
  • Participate in equipment upgrades, capacity expansion, and automation projects.

Qualifications and Experience:

  • Bachelor’s Degree in Mechanical, Manufacturing, Biomedical, or Industrial Engineering (or equivalent).
  • 3+ years of experience in a manufacturing engineering role, ideally within the medical device or pharmaceutical industry.
  • Strong understanding of GMP, ISO 13485, and FDA regulatory requirements.
  • Proven experience with process validation (IQ/OQ/PQ), equipment qualification, and risk management.
  • Demonstrated ability to apply Lean Manufacturing and Six Sigma principles to process improvement.
  • Excellent problem-solving, analytical, and communication skills.
  • Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.

For a confidential discussion on the Manufacturing Engineer role, please contact Emma Barry today.

emma.barry@collinsmcnicholas.ie

091 706719