Medical Device Process Engineer - Lean Manufacturing

Kanry Search

Iskandar Puteri

On-site

MYR 71,000 - 85,000

Full time

4 days ago

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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.