Senior Process Development Engineer

The Opportunity

CREGG are hiring for a Senior Process Development Engineer to a leading medical device manufacturing environment.

This is a hands-on role combining 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.

Key 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.

Requirements

• Level 8 degree in Engineering or a related discipline.
• 5+ years' relevant engineering experience, ideally within medical device or another regulated manufacturing environment.
• Strong experience in process development, manufacturing engineering and process optimisation.
• Knowledge of process validation, risk management and structured problem solving.
• Strong understanding of 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.

INDTRAC