Chief Manufacturing Process Engineer

2 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €60,000 - €80,000

Drive Advanced Manufacturing Processes for Medical Devices

This is a key role in driving business growth and compliance with international standards in the medical device industry.

About the Role:
  • The successful candidate will play a key role in leading advanced manufacturing processes for Class II/III medical devices.
  • They will provide technical leadership and mentorship to engineers and technicians ensuring stable, efficient, and compliant manufacturing operations.
  • The ideal candidate will have strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR) and experience in medical device manufacturing with leadership responsibilities.
Responsibilities:
  1. Provide technical guidance and support to teams to ensure stable, efficient, and compliant manufacturing operations.
  2. Lead complex troubleshooting efforts using advanced problem-solving techniques.
  3. Develop and implement continuous improvement initiatives using Lean, Six Sigma, and other methodologies.
  4. Ensure process and equipment change control activities are conducted to maintain quality and regulatory compliance.
  5. Oversee equipment and process validations (IQ, OQ, PQ) to ensure they meet quality standards.
  6. Analyze root causes of non-conformances and implement effective corrective actions.
Requirements:
  • Bachelor's degree in Mechanical, Manufacturing, Biomedical or related engineering discipline.
  • 6-9 years' experience in medical device manufacturing with leadership responsibilities.
  • Strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR).

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