Process Engineer (Medical Device Manufacturing)

Kanry Search; Iskandar Puteri; On-site; MYR 71,000 - 85,000; Full time

Job summary

Kanry Search Singapore Pte Ltd is hiring a Process Engineer for Medical Device Manufacturing in Iskandar Puteri, Johor. The role focuses on developing, improving and optimizing manufacturing processes to boost quality, productivity and cost efficiency.

You will lead process validation (IQ/OQ/PQ), support NPI and product transfers, ensure compliance with ISO 13485 and customer specs, and drive continuous improvement by reducing scrap and downtime while improving OEE and process capability.

Qualifications

• Diploma or Degree in Mechanical/ Manufacturing/ Industrial/ Mechatronics/ Materials Engineering or related field.
• Experience in Process Engineering or Production Engineering within manufacturing.
• Experience in medical device manufacturing or regulated environments is a plus.
• Familiarity with ISO 13485 and manufacturing quality systems.
• Experience with process validation (IQ, OQ, PQ) and documentation.
• Knowledge of Cp/Cpk, yield improvement and process optimization.

Responsibilities

• Develop, improve and optimize manufacturing processes to enhance quality, productivity, yield, cycle time and cost efficiency.
• Monitor process performance and conduct Cp/Cpk analysis to identify opportunities.
• Plan, execute and support process validation activities (IQ/OQ/PQ) to keep processes validated.
• Ensure processes comply with ISO 13485, customer specs and regulatory requirements.
• Provide technical support to production teams for process troubleshooting and defect reduction.
• Conduct root cause investigations and implement corrective actions (8D, 5 Why).
• Drive continuous improvement to reduce scrap, defects and downtime.
• Prepare and maintain documentation: Process Flow, PFMEA, Control Plans, Work Instructions.
• Support NPI, product transfers, process development and risk assessments.
• Support PPAP and customer qualification activities; participate in Lean projects.
• Monitor KPIs like OEE, yield, scrap rate and process capability.
• Support audits related to manufacturing processes and quality systems.

Skills

Process engineering

Manufacturing engineering

Quality systems

Problem solving

Lean manufacturing

NPI involvement

Education

Mechanical Engineering

Manufacturing Engineering

Industrial Engineering

Mechatronics

Materials Engineering

Job description

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.

Kanry Search Singapore Pte Ltd | 24C2261
Doreen Oh |R1326597

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