Senior Process Engineer: MedTech Automation & Lean Leader

Cregg Recruitment; Galway; On-site; EUR 75,000 - 97,000; Full time

Job summary

A Galway-based medical device manufacturer is seeking a Senior Process Engineer to lead development projects and provide direct line support to manufacturing operations.

You will troubleshoot issues with production teams, stabilise processes, and implement Lean improvements while driving automation and ensuring compliance with ISO 13485 and FDA requirements.

The role requires a Level 8 engineering degree with 5+ years of relevant experience and a proactive, collaborative approach.

Qualifications

• Engineering degree (Level 8) or related discipline.
• 5+ years of experience in medical device process development.
• Strong knowledge of Lean, Six Sigma and quality systems.
• Experience with ISO 13485 and FDA regulations is preferred.
• Proficiency with AutoCAD/SolidWorks for process layouts.

Responsibilities

• Lead development projects and support manufacturing operations to stabilize processes.
• Collaborate with production teams to scale up output and meet growth targets.
• Drive automation initiatives and ensure compliance with quality/regulatory standards.
• Apply structured problem-solving to CAPA, deviations, and process validation.
• Develop and maintain SOPs and technical documentation for training.

Job description

A Galway-based medical device manufacturer is seeking a Senior Process Engineer to lead development projects and provide direct line support to manufacturing operations.

You will troubleshoot issues with production teams, stabilise processes, and implement Lean improvements while driving automation and ensuring compliance with ISO 13485 and FDA requirements.

The role requires a Level 8 engineering degree with 5+ years of relevant experience and a proactive, collaborative approach.