NPI Engineer (Process Integration)

Ambu; Seberang Perai; Presencial; MYR 72 000 - 120 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Problem solving

Analytical skills

Communication

Project management

Stakeholder management

Quality systems knowledge

Formação académica

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

Descrição da oferta de emprego

Ambu is currently looking for a NPI Engineer (Process Integration) to be based in Global Hub Penang. This position is part of our R&D NPI team.

Key Responsibilities

• Collaborate with the Engineering and Imaging team to understand product specifications and requirements.
• Partner with the Process Engineering team to develop manufacturing processes and work closely with the Equipment Development & Automation team to design and develop necessary equipment.
• Lead the 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 potential 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 clearly transferred.

Suggested candidate profile

• 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.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.