Manufacturing Process Engineer II - Medical Devices, NPI

ResMed Inc; Johor Bahru; On-site; MYR 60,000 - 120,000; Full time

Job summary

ResMed Inc. in Malaysia seeks a Manufacturing Engineer II to develop, optimize, validate, and sustain manufacturing processes for mask products. You will work across Production, Quality, Product Development, and Global Engineering to improve safety, efficiency, and scalability in a regulated medical device environment.

The role emphasizes hands-on problem solving, CAPA ownership, process validation (IQ/OQ/PQ), and cross-functional collaboration to meet quality, delivery, and cost targets.

Qualifications

• Bachelor's degree in a engineering discipline (Mechanical, Manufacturing, Mechatronics, Biomedical or Industrial) required.
• 2-4 years of Manufacturing Engineering experience in a regulated environment required.
• Experience with process validation (IQ/OQ/PQ) preferred.
• Experience supporting production and manufacturing operations.
• Strong root cause analysis and troubleshooting skills.

Responsibilities

• Support mask manufacturing operations and resolve process issues.
• Lead CAPA implementation and effectiveness verification.
• Develop and optimize manufacturing processes for capability, reliability, quality and productivity.
• Validate processes per IQ/OQ/PQ and maintain validated state.
• Collaborate with cross-functional teams and support audits and compliance.

Skills

Root cause analysis

Troubleshooting

Problem solving

Cross-functional collaboration

Lean Manufacturing

Six Sigma

Statistical tools

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Manufacturing Engineering

Bachelor's Degree in Mechatronics Engineering

Bachelor's Degree in Biomedical Engineering

Bachelor's Degree in Industrial Engineering

Tools

Statistical software (e.g., Minitab)

Job description

ResMed Inc. in Malaysia seeks a Manufacturing Engineer II to develop, optimize, validate, and sustain manufacturing processes for mask products. You will work across Production, Quality, Product Development, and Global Engineering to improve safety, efficiency, and scalability in a regulated medical device environment.

The role emphasizes hands-on problem solving, CAPA ownership, process validation (IQ/OQ/PQ), and cross-functional collaboration to meet quality, delivery, and cost targets.