Process Engineer (Medical Device Manufacturing)

Position: Process Engineer
Industry: Medical Device Manufacturing - Life science
Location: Iskandar Puteri, Johor
Salary: Up to RM7,000

Job Responsibilities

• Develop, improve and optimize manufacturing processes to enhance quality, productivity, yield, cycle time and cost efficiency.

• Monitor process performance and conduct process capability analysis, including Cp/Cpk, to identify opportunities for improvement.

• Plan, execute and support process validation activities, including IQ, OQ and PQ, to ensure manufacturing processes remain validated and controlled.

• Ensure manufacturing processes comply with ISO 13485, customer specifications and applicable regulatory requirements.

• Provide technical support to production teams on process troubleshooting, defect reduction and manufacturing-related issues.

• Conduct root cause investigations and implement corrective actions using methodologies such as 8D, 5 Why and Root Cause Analysis.

• Drive continuous improvement initiatives to reduce scrap, defects, downtime and process variation.

• Prepare and maintain manufacturing documentation, including Process Flow, PFMEA, Control Plans, Work Instructions, Operating Instructions and validation documents.

• Support New Product Introduction (NPI), product transfers, process development, risk assessments and qualification activities.

• Support PPAP and customer qualification activities where applicable.

• Participate in Lean Manufacturing and continuous improvement projects to improve operational efficiency and manufacturing performance.

• Monitor and improve manufacturing KPIs such as OEE, yield, scrap rate and process capability.

• Support internal, customer and regulatory audits related to manufacturing processes and quality systems.

Job Requirements

• Diploma or Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Mechatronics, Materials Engineering or a related discipline.
• Relevant experience in Process Engineering, Manufacturing Engineering or Production Engineering within a manufacturing environment.
• Experience in medical device manufacturing or other regulated manufacturing environments will be an advantage.
• Familiarity with ISO 13485 and manufacturing quality systems.
• Practical experience in process validation, including IQ, OQ and PQ.
• Knowledge of preparing and maintaining Process Flow, PFMEA, Control Plans and Work Instructions.
• Familiarity with Cp/Cpk, process capability analysis, yield improvement and process optimization.
• Strong analytical and problem-solving skills, with knowledge of 8D, 5 Why and Root Cause Analysis.
• Experience in NPI, product transfer, PPAP, Lean Manufacturing or continuous improvement activities will be an advantage.

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Doreen Oh | R1326597