Senior Process Development Engineer – Medical Devices

CREGG; Galway; On-site; EUR 80,000 - 110,000; Full time

Job summary

CREGG is seeking a Senior Process Development Engineer for our Galway medical device manufacturing client. The role leads key development projects, designing, developing, and validating robust processes to ensure safe, compliant production.

The successful candidate will collaborate with cross-functional teams, apply Lean and Six Sigma to drive improvements, and oversee automation initiatives from concept to implementation in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years of experience in medical device process development.
• Experience in manufacturing, project/program management.
• Knowledge of ISO 13485 and FDA regulatory requirements.
• Proficient in DOE and Six Sigma methodologies.

Responsibilities

• Lead development projects to design, develop, and validate scalable manufacturing processes for medical devices.
• Collaborate with engineering and production teams to optimize manufacturing systems and strategies.
• Drive automation initiatives while ensuring regulatory compliance and quality.
• Identify process improvements using Lean methodologies and CAPA management.
• Develop and validate experiments and documentation, including work instructions and protocols.
• Evaluate new technologies for performance, cost, and reliability.

Skills

Project leadership

Cross-functional collaboration

DOE / Six Sigma

Regulatory knowledge ISO13485 / FDA

Manufacturing process development

Education

Bachelor's degree in Engineering

Tools

DOE Software

Statistical analysis (Minitab)

Job description

CREGG is seeking a Senior Process Development Engineer for our Galway medical device manufacturing client. The role leads key development projects, designing, developing, and validating robust processes to ensure safe, compliant production.

The successful candidate will collaborate with cross-functional teams, apply Lean and Six Sigma to drive improvements, and oversee automation initiatives from concept to implementation in a regulated environment.