Senior Process Engineer: Medical Devices & Automation Lead

CREGG; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

CREGG is hiring a Senior Process Development Engineer for a leading medical device manufacturing environment. This hands-on role combines process development, automation, validation and continuous improvement, with the opportunity to take ownership of key engineering projects and directly influence manufacturing performance.

You will work closely with Manufacturing, Quality and Engineering teams to develop robust processes, introduce new technologies and solve complex production challenges.

Qualifications

• Level 8 degree in Engineering or related discipline.
• 5+ years' relevant engineering experience, ideally within medical device or regulated manufacturing.
• Strong experience in process development, manufacturing engineering and process optimisation.
• Knowledge of process validation, risk management and structured problem solving.
• Lean Manufacturing / Six Sigma methodologies.
• Knowledge of ISO 13485 and FDA requirements.
• Experience with DOE, statistical analysis or process capability.
• Experience with automation, robotics or vision systems is advantageous.
• Lean Six Sigma Green Belt would be an advantage.
• Experience with SolidWorks, AutoCAD or similar engineering software.
• Strong communication, organisational and project management skills.

Responsibilities

• Develop, optimise and scale manufacturing processes to meet quality, cost and productivity targets.
• Lead process improvement and automation projects from concept through to implementation.
• Provide technical support to manufacturing, troubleshooting process, equipment and material issues.
• Drive Lean and continuous improvement initiatives using tools such as DMAIC, Kaizen and Value Stream Mapping.
• Evaluate and implement automation technologies including robotics, vision systems and digital monitoring.
• Lead process development studies, experiments and equipment/process validation activities.
• Investigate and resolve complex manufacturing and quality issues, including CAPA and non-conformances.
• Develop technical documentation, procedures and training materials to support production.
• Work with cross-functional teams to assess and implement new technologies that improve efficiency, reliability and scalability.

Skills

Process development

Manufacturing engineering

Lean Six Sigma

DOE & statistics

Problem solving

Automation projects

Project management

Cross-functional collaboration

Quality systems

Education

Engineering degree (Level 8)

Tools

SolidWorks

AutoCAD

Job description

CREGG is hiring a Senior Process Development Engineer for a leading medical device manufacturing environment. This hands-on role combines process development, automation, validation and continuous improvement, with the opportunity to take ownership of key engineering projects and directly influence manufacturing performance.

You will work closely with Manufacturing, Quality and Engineering teams to develop robust processes, introduce new technologies and solve complex production challenges.