Lead Medical Device Process Engineer (Automation & Lean)

CREGG; Galway; On-site; EUR 75,000 - 105,000; Full time

Job summary

CREGG in Galway seeks a Senior Process Development Engineer for a permanent role to lead key development projects and design, develop, and validate robust, scalable processes ensuring safe and compliant medical device production.

The candidate will collaborate with engineers and production teams, drive automation initiatives, and apply Lean methodologies to improve cost, quality, and throughput. Strong regulatory knowledge and DOEs expected.

Qualifications

• 5+ years of relevant experience in engineering.
• Proven experience in medical device process development and manufacturing.
• Knowledge of ISO 13485 and FDA regulatory requirements.
• Excellent organizational and interpersonal skills.
• Proficiency in statistical techniques (DOE, Six Sigma).

Responsibilities

• Collaborate with engineers and production teams to develop manufacturing processes.
• Lead automation initiatives and integrate with existing processes.
• Identify process improvements using Lean methodologies.
• Develop validation protocols and technical reports.
• Address CAPA and audit observations.
• Prepare training materials for production teams.

Skills

Process development

Project management

Six Sigma

DOE

Team player

Education

Level 8 Engineering degree

Tools

AutoCAD

SolidWorks

Job description

CREGG in Galway seeks a Senior Process Development Engineer for a permanent role to lead key development projects and design, develop, and validate robust, scalable processes ensuring safe and compliant medical device production.

The candidate will collaborate with engineers and production teams, drive automation initiatives, and apply Lean methodologies to improve cost, quality, and throughput. Strong regulatory knowledge and DOEs expected.