Manufacturing Process Engineer II – Medical Devices

Medifox DAN GmbH; Kulai; Sur place; MYR 80 000 - 120 000; Plein temps

Résumé du poste

Medifox DAN GmbH is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain manufacturing processes for mask products. You will collaborate with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, efficient, and scalable operations.

This role emphasizes technical problem solving, project execution, and cross-functional teamwork in a regulated medical device environment, including NPI activities and process improvement

Qualifications

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

Responsabilités

• 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.

Connaissances

Root cause analysis

Troubleshooting

CAPA implementation

Lean manufacturing

Six Sigma

Statistical tools

Process validation

IQ/OQ/PQ

Formation

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Manufacturing Engineering

Bachelor's Degree in Mechatronics Engineering

Outils

SolidWorks

AutoCAD

Minitab

Description du poste

Medifox DAN GmbH is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain manufacturing processes for mask products. You will collaborate with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, efficient, and scalable operations.

This role emphasizes technical problem solving, project execution, and cross-functional teamwork in a regulated medical device environment, including NPI activities and process improvement