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Ambu5 days ago

NPI Engineer (Process Integration)

On-site · George Town, Penang, Malaysia

Type
Full Time
Level
Mid Level
Education
Masters Degree
Company size
Large

Job Summary

NPI Engineer (Process Integration) to lead end-to-end production line setup, collaborate with the Engineering and Imaging teams to understand product specifications and requirements, partner with Process Engineering to develop manufacturing processes, and work with Equipment Development & Automation to design and develop required equipment. Responsible for readiness of processes, equipment, and supporting infrastructure; ensure equipment installation and registration are completed as an integrated production package prior to line release; conduct process design reviews for manufacturability; facilitate pilot runs and pre-production builds; ensure documentation, work instructions, and training align to support Operations ownership; drive structured handover of production lines to Operations with clear ownership transfer. Requires strong understanding of product specs, manufacturing processes, FDA compliance for medical devices, and excellent problem-solving and collaboration skills.

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Ambu

NPI Engineer (Process Integration)

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