Medical Device Process Improvement Engineer

Pentamaster; Seberang Perai; On-site; MYR 40,000 - 65,000; Full time

Job summary

Jora Malaysia is seeking an Industrial/Manufacturing Engineer in Penang to drive process efficiency across plastics injection moulding, automated assembly, and test equipment for medical devices. You will balance throughput, cost and quality under strict compliance standards.

Ideal candidates hold a degree in Industrial/Manufacturing/Mechanical/Mechatronic Engineering with 2+ years in medical device/automation, plus knowledge of ISO 13485 and exposure to FDA 21 CFR 820, cleanroom, and validation.

Qualifications

• Degree in Industrial/Manufacturing/Mechanical/Mechatronic Engineering.
• 2+ years in medical device, semiconductor, or automation/ATE manufacturing.
• Knowledge of ISO 13485; exposure to FDA 21 CFR 820, cleanroom, and validation.

Responsibilities

• Optimize manufacturing processes, layouts, and line balancing.
• Run time & motion, capacity, and cycle-time studies to lift OEE and productivity.
• Support DFM/DFA reviews and process validation (IQ/OQ/PQ).
• Maintain PFMEA, control plans, work instructions, and routings.
• Apply Lean / Six Sigma and drive corrective actions (8D, CAPA).

Skills

Process optimization

Line balancing

OEE improvement

Lean Six Sigma

DFM/DFA

IQ/OQ/PQ validation

PFMEA

CAPA / 8D

Education

Bachelors in Industrial/Manufacturing/Mechanical/Mechatronic Engineering

Tools

ISO 13485

FDA 21 CFR 820

Cleanroom

Validation

Job description

Jora Malaysia is seeking an Industrial/Manufacturing Engineer in Penang to drive process efficiency across plastics injection moulding, automated assembly, and test equipment for medical devices. You will balance throughput, cost and quality under strict compliance standards.

Ideal candidates hold a degree in Industrial/Manufacturing/Mechanical/Mechatronic Engineering with 2+ years in medical device/automation, plus knowledge of ISO 13485 and exposure to FDA 21 CFR 820, cleanroom, and validation.