Process Engineer

About the role

An established precision manufacturing company supporting the medical technology and life sciences sectors is seeking an experienced Process Engineer with hands-on exposure to medical device manufacturing and regulated production environments.

Key responsibilities

• Design, establish and enhance manufacturing processes to improve product quality, productivity, yield, cycle time and production costs.
• Analyse process performance and carry out capability assessments, including Cp and Cpk studies, to identify opportunities for improvement.
• Plan, execute and document process validation activities covering Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Maintain validated and well-controlled manufacturing processes in accordance with ISO 13485, customer specifications and applicable regulatory requirements.
• Work closely with production teams to troubleshoot manufacturing issues, minimise defects and resolve process-related problems.
• Investigate process failures and implement effective corrective actions using structured problem-solving methods such as 8D, 5 Why and Root Cause Analysis.
• Initiate improvements aimed at reducing scrap, production defects, equipment downtime and process variation.
• Track and enhance manufacturing performance indicators, including OEE, production yield, scrap rate and customer quality results.
• Prepare, review and update manufacturing documents such as Process Flows, PFMEA, Control Plans, Work Instructions, Operating Instructions and validation records.
• Participate in New Product Introduction (NPI), manufacturing transfers, process development, risk assessments and qualification activities.

About you

• Diploma or Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Mechatronics, Materials Engineering or a related technical discipline.
• Relevant experience as a Process Engineer, Manufacturing Engineer or Production Engineer within a manufacturing environment.
• Hands-on experience in medical device, medical technology or life sciences manufacturing is required.
• Good working knowledge of ISO 13485 and regulated manufacturing quality systems.
• Practical experience in planning or executing IQ, OQ and PQ process validation activities.
• Familiar with the preparation and maintenance of Process Flows, PFMEA, Control Plans, Work Instructions and validation documentation.
• Knowledge of Cp/Cpk analysis, process capability improvement, yield enhancement and process optimisation.
• Strong analytical and troubleshooting abilities, with practical experience using 8D, 5 Why and Root Cause Analysis.
• Able to work effectively with production, quality, engineering and other cross-functional teams.