Lead Medical Device Manufacturing Engineer

Gi Group; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Gi Group is seeking a Senior Manufacturing Engineer in Galway to lead manufacturing engineering activities that ensure safe, cost-effective production of medical devices. You will drive process development, validation, and cross-functional leadership to support scalable manufacturing in line with quality regulations.

Responsibilities include process optimization, validation, and the implementation of automation and Lean Six Sigma initiatives, with focus on continuous improvement and data-driven

Qualifications

• Degree in Mechanical, Manufacturing, Biomedical or Industrial Engineering.

Responsibilities

• Lead manufacturing processes to meet Safety, Quality, Delivery, and Cost targets.
• Lead process development and industrialisation for new/existing products, including transfers from R&D or external suppliers.
• Provide technical leadership on complex issues and implement robust corrective actions.
• Define and execute process capability improvements (Cp/Cpk, yield, scrap reduction).
• Lead/coordinate process validation (IQ/OQ/PQ, PPQ where relevant).
• Support risk management and ensure mitigation actions are sustained.
• Ensure accurate, audit-ready manufacturing documentation (SOPs, routes, control plans).
• Support regulatory and customer audits with technical input and evidence.

Skills

Process optimization

Root cause analysis

Cross-functional leadership

Data analysis

Problem solving

Education

Engineering degree

Tools

FAT/SAT procedures

Job description

Gi Group is seeking a Senior Manufacturing Engineer in Galway to lead manufacturing engineering activities that ensure safe, cost-effective production of medical devices. You will drive process development, validation, and cross-functional leadership to support scalable manufacturing in line with quality regulations.

Responsibilities include process optimization, validation, and the implementation of automation and Lean Six Sigma initiatives, with focus on continuous improvement and data-driven