Job Title: Process Engineer
Location: Castlebar Co. Mayo
Reports To: Manufacturing Manager
Employment Type: Full time

About the Role:
We are seeking a detail-oriented and innovative Process Engineer to join our Clients team in the medical manufacturing sector. This role is critical to ensuring the efficiency, quality, and compliance of our production processes, with a strong focus on continuous improvement and adherence to regulatory standards.

Key Responsibilities:

• Design, implement, and optimize manufacturing processes for medical devices/products.
• Analyze production data to identify inefficiencies and recommend improvements.
• Collaborate with cross-functional teams including Quality Assurance, R&D, and Regulatory Affairs.
• Ensure processes comply with ISO 13485, FDA regulations, and other relevant standards.
• Lead root cause analysis and corrective/preventive actions (CAPA) for process-related issues.
• Develop and maintain process documentation including SOPs, work instructions, and validation protocols.
• Support scale-up of new products from development to full production.
• Train production staff on new processes and equipment.
• Participate in audits and inspections as a process subject matter expert.

Required Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
• 3+ years of experience in process engineering within a regulated manufacturing environment, preferably medical devices or pharmaceuticals.
• Strong understanding of GMP, ISO 13485, and FDA requirements.
• Experience with process validation, statistical analysis, and lean manufacturing principles.
• Proficiency in CAD software and data analysis tools (e.g., Minitab, Excel).
• Excellent problem-solving and communication skills.

• Master’s degree in Engineering or related discipline.
• Six Sigma certification or experience with lean methodologies.
• Experience with automation and advanced manufacturing technologies.
• Knowledge of risk management tools (FMEA, HACCP).

KSGalway

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Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Gold status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.

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