Manufacturing Process Engineer II — Medical Devices

ResMed Inc; Kulai; On-site; MYR 120,000 - 180,000; Full time

Job summary

ResMed Inc. is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain mask manufacturing processes across the product lifecycle.

You will partner with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, and scalable operations in a regulated medical-device environment. The role emphasizes problem-solving, project execution, and cross-functional collaboration to drive continuous improvement and manufacturing

Qualifications

• Bachelor's degree in a relevant engineering field.
• 2-4 years of manufacturing engineering in a regulated environment.
• Experience with process validation (IQ/OQ/PQ).
• Strong root cause analysis and troubleshooting skills.
• Knowledge of ISO 13485, FDA QSR and GMP preferred.

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 utilizing structured problem-solving tools.
• Drive CAPA implementation and effectiveness verification.
• Support production performance targets for safety, quality, delivery, and cost.
• Develop and optimize manufacturing processes to improve capability, reliability, quality, and productivity.
• Establish process controls and monitoring strategies.
• Conduct process characterization and capability analysis.
• Identify opportunities for process automation, error-proofing, and waste reduction.
• Support capacity and line balancing initiatives to meet business demand.
• Develop fixtures, tooling, and automation solutions to improve process robustness.
• Utilize engineering and statistical tools to support decision-making.

Skills

Root cause analysis

CAPA

Lean Manufacturing

Six Sigma

Cross-functional collaboration

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

Tools

IQ/OQ/PQ

Job description

ResMed Inc. is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain mask manufacturing processes across the product lifecycle.

You will partner with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, and scalable operations in a regulated medical-device environment. The role emphasizes problem-solving, project execution, and cross-functional collaboration to drive continuous improvement and manufacturing