Manufacturing Process Engineer II - Medical Devices

ResMed; Kulai; On-site; MYR 67,000 - 100,000; Full time

Job summary

ResMed is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain mask manufacturing processes across product lifecycles. You will partner with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, and scalable operations.

This role emphasizes technical problem-solving, project execution, and cross-functional collaboration in a regulated medical device environment.

Qualifications

• Bachelor’s degree in a related engineering discipline.
• 2–4 years of regulated manufacturing experience.
• Experience with IQ/OQ/PQ validation.
• Experience supporting production operations.
• Strong root cause analysis and troubleshooting skills.

Responsibilities

• Provide technical leadership and engineering support to mask manufacturing operations.
• Investigate and resolve manufacturing process, equipment, and product quality issues; lead root cause investigations and CAPA.
• Develop and optimize manufacturing processes to improve capability, reliability, quality, and productivity.
• Maintain compliance with ISO 13485, FDA QSR, GMP and internal quality systems.
• Collaborate with cross-functional teams including Production, Quality, Product Development, Supply Chain, and Global Engineering.

Skills

Root cause analysis

Troubleshooting

Cross-functional collaboration

Process improvement

Education

Mechanical Engineering

Manufacturing Engineering

Mechatronics Engineering

Job description

ResMed is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain mask manufacturing processes across product lifecycles. You will partner with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, and scalable operations.

This role emphasizes technical problem-solving, project execution, and cross-functional collaboration in a regulated medical device environment.