Manufacturing Engineer - Onsite | Lean & Quality Champion

Sigmar Recruitment; Galway; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Career development

Lean/Six Sigma training

Comprehensive benefits package

Job summary

Sigmar Recruitment is seeking a Manufacturing Engineer for an onsite role in Galway within the medical devices sector. You will support the manufacturing line, lead root-cause investigations, and ensure CAPAs are effectively implemented to maintain quality and compliance.

You will collaborate with multidisciplinary teams on process development, validation activities (IQ/OQ/PQ), and documentation. A strong Lean/Six Sigma background and GMP awareness are essential.

Qualifications

• 3–5 years hands-on experience in the medical device or pharmaceutical production environment.
• Knowledge of ISO 13485, MDR, and FDA regulatory requirements within a QMS.
• Strong analytical and troubleshooting skills, ownership mentality, and teamwork.

Responsibilities

• Provide ongoing engineering support to the manufacturing line to ensure stable, efficient operations.
• Lead root cause analysis for complex equipment/process issues and implement CAPAs.
• Manage process and equipment change control with validation and documentation per QMS standards.
• Identify and deploy new tools, jigs, fixtures, or process improvements to boost quality and efficiency.
• Drive continuous improvement initiatives using Lean or Six Sigma methodologies.
• Collaborate with cross-functional teams on risk management, development, and validation projects (IQ/OQ/PQ).
• Develop, review and maintain technical documents, SOPs, and work instructions.
• Support GMP-compliant, safe, and orderly production environments and training.

Skills

Lean Manufacturing

Six Sigma Green Belt

Problem solving

Autonomous work

Communication

Documentation

Education

Bachelor’s degree in Engineering

Job description

Sigmar Recruitment is seeking a Manufacturing Engineer for an onsite role in Galway within the medical devices sector. You will support the manufacturing line, lead root-cause investigations, and ensure CAPAs are effectively implemented to maintain quality and compliance.

You will collaborate with multidisciplinary teams on process development, validation activities (IQ/OQ/PQ), and documentation. A strong Lean/Six Sigma background and GMP awareness are essential.