NPI Process Integration Engineer (Global Launch)

Ambu; Seberang Perai; On-site; MYR 72,000 - 120,000; Full time

Job summary

Ambu is seeking an NPI Engineer (Process Integration) to join the Global Hub Penang. You will collaborate with Engineering, Imaging and Process Engineering teams to develop and transfer manufacturing processes, and lead end-to-end production line setup with a focus on readiness of processes and equipment.

The role requires strong understanding of product specifications, manufacturing processes, and equipment, plus experience in product integration within manufacturing or R&D environments and

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• Experience in product integration within a manufacturing or R&D environment is a plus.
• Experience with global production line transfers and dual manufacturing initiatives.
• Strong understanding of product specifications and requirements, manufacturing processes, and equipment.
• Possessing project management or stakeholder management skills is a plus.
• Proficiency in quality systems and standards, along with knowledge of FDA regulations and compliance requirements for medical devices.
• Excellent problem-solving and analytical skills.
• Effective communication and collaboration skills.

Responsibilities

• Collaborate with Engineering and Imaging teams to understand product specifications and requirements.
• Partner with Process Engineering to develop manufacturing processes and with Equipment Development & Automation to design equipment.
• Lead end-to-end production line setup, including 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 review to ensure manufacturability and alignment with production expectations before line deployment and handover.
• Facilitate pilot runs and pre-production builds, identify gaps, and ensure readiness for downstream process validation activities.
• Ensure documentation, work instructions, and training are completed and aligned to support Operations ownership.
• Drive structured handover of production lines to Operations, ensuring acceptance criteria are met and ownership is transferred.

Skills

Problem solving

Analytical skills

Communication

Project management

Stakeholder management

Quality systems knowledge

Education

Bachelor's or Master's in Mechanical/Manufacturing Engineering

Job description

Ambu is seeking an NPI Engineer (Process Integration) to join the Global Hub Penang. You will collaborate with Engineering, Imaging and Process Engineering teams to develop and transfer manufacturing processes, and lead end-to-end production line setup with a focus on readiness of processes and equipment.

The role requires strong understanding of product specifications, manufacturing processes, and equipment, plus experience in product integration within manufacturing or R&D environments and