Manufacturing Process Engineer (MNC)

Kanry Search; Iskandar Puteri; On-site; MYR 60,000 - 90,000; Full time

Job summary

Kanry Search is seeking a process and manufacturing engineer to drive improvements in our medical devices manufacturing, ensuring production remains efficient, validated, and compliant.

You will lead process capability studies, optimise parameters, and support IQ/OQ/PQ activities while maintaining ISO 13485 alignment and documentation.

Collaborate with cross-functional teams on NPI and product transfers, resolve process issues, and drive quality, cost, and delivery improvements.

Qualifications

• Diploma or degree in mechanical/manufacturing/industrial engineering or related.
• Experience in process engineering or production engineering in a manufacturing environment.
• Experience in medical device manufacturing or regulated industries is a plus.
• Knowledge of ISO 13485 and manufacturing quality systems.
• Hands-on experience with IQ/OQ/PQ and process validation.
• Familiar with Cp/Cpk, PFMEA, Control Plan and related documentation.

Responsibilities

• Develop, introduce and refine manufacturing processes to meet product quality, production output and cost targets.
• Apply process engineering methods to strengthen process capability, improve productivity and efficiency.
• Optimise production parameters, cycle times, yields and equipment utilisation while minimising scrap, defects and downtime.
• Perform process capability studies (Cp/Cpk) and implement improvements.
• Lead IQ/OQ/PQ activities and maintain validated state of processes.
• Maintain validation documentation and ensure compliance with ISO 13485 and regulatory requirements.
• Provide hands-on engineering support to production teams and troubleshoot issues.
• Support New Product Introduction (NPI) and product transfers by establishing stable manufacturing processes.
• Participate in audits and provide process information and documentation.
• Collaborate with cross-functional teams to improve quality, cost, delivery and overall operations.

Skills

Process engineering

Manufacturing engineering

Cross-functional collaboration

Education

Engineering degree (Mechanical/Manufacturing/Industrial)

Job description

Drive process engineering and manufacturing engineering improvements within the medical devices division, ensuring production processes remain efficient, consistent and validated. Support product quality, regulatory compliance and customer satisfaction through effective process control and continuous improvement.

Key responsibilities

• Develop, introduce and refine manufacturing processes to meet product quality, production output and cost targets.
• Apply process engineering and manufacturing engineering methods to strengthen process capability, improve productivity and increase manufacturing efficiency.
• Optimise production parameters, cycle times, yields and equipment utilisation while minimising scrap, defects and downtime.
• Perform process capability studies, including Cp/Cpk analysis, and implement improvements based on the findings.
• Lead Installation Qualification, Operational Qualification and Performance Qualification (IQ/OQ/PQ) activities, ensuring manufacturing processes remain in a validated state.
• Maintain process validation documentation and ensure manufacturing activities meet ISO 13485, customer specifications and applicable regulatory requirements.
• Provide hands-on engineering support to production teams, troubleshoot process issues and implement effective solutions.
• Support New Product Introduction (NPI) and product transfers by helping establish stable and reliable manufacturing processes.
• Participate in internal, customer and regulatory audits, providing relevant process information and supporting documentation.
• Work closely with cross-functional teams to improve quality, cost, delivery and overall operational performance.

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 highly regulated manufacturing industries will be an added advantage.
• Familiar with ISO 13485 requirements and manufacturing quality systems.
• Hands-on experience in process validation, including IQ, OQ and PQ.
• Knowledge of Process Flow, PFMEA, Control Plan and Work Instruction preparation and maintenance.
• Familiar with process capability analysis such as Cp/Cpk, yield improvement and process optimization.
• Strong problem-solving skills with experience using tools such as 8D, 5 Why and root cause analysis.