Chief Manufacturing Process Developer

2 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €90,000 - €105,000

Job Title: Senior Manufacturing Engineer

Job Description:

This is an exciting opportunity for a seasoned engineer to lead the development and optimization of advanced manufacturing processes for medical devices. As a key member of our team, you will play a crucial role in driving business growth while ensuring compliance with international standards.

The ideal candidate will have strong leadership skills, a passion for continuous improvement, and a proven track record in medical device manufacturing.

Key Responsibilities:
  • Provide technical guidance and mentorship to engineers and technicians to ensure stable, efficient, and compliant manufacturing operations.
  • Lead complex troubleshooting efforts using advanced problem-solving techniques to resolve equipment, tooling, process, or material issues.
  • Develop and implement continuous improvement initiatives using Lean and Six Sigma methodologies to drive efficiency and quality.
  • Oversee process and equipment change control activities to ensure quality and regulatory compliance.
  • Lead the strategy, planning, and execution of equipment and process validations (IQ, OQ, PQ).
  • Conduct root cause investigations for non-conformances and develop effective corrective and preventive actions (CAPA).
  • Collaborate cross-functionally on new product introductions, risk management (e.g., FMEAs), and technology transfers.
Requirements:
  • Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline).
  • 6–9 years' experience in medical device or pharmaceutical manufacturing with proven leadership and mentoring responsibilities.
  • Strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR).
  • Demonstrated expertise in process validation (IQ/OQ/PQ) and change control.
  • Skilled in continuous improvement methodologies (Lean, Six Sigma – Green Belt preferred).
What We Offer:
  • Cutting-edge manufacturing processes for medical devices.
  • Leadership development opportunities with cross-functional project ownership.
  • Competitive salary and benefits package.
  • Collaborative and innovative team environment.

We appreciate your interest in this opportunity and thank you for considering it.

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