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

• Accountable for raw materials qualification activities which includes providing inputs during development of drawings and item specifications, inspecting, measuring or testing raw materials against drawings and item specifications, plus compiling first sample approval (FSA) reports.
• Carry out BOM creation and implementation activities in cooperation with other functions within R&D, plus other relevant stakeholders within Operations.
• Work with Engineering team members to create incoming QC inspection work instructions and specify the appropriate tests and acceptance criteria, plus ensuring alignment with outgoing inspection criteria.
• Work with NPI team members to create manufacturing procedures in a simple, clear, and structured manner to align with operational needs.
• Support creation and approval of R&D and NPI documentation including but not limited to raw material, WIP or FG, process development and validation documentation.
• Ensure documentation follows procedure and tools as described in Ambu Quality System and of relevant authorities, and continuously give input for improvement.
• Carry out projects/ activities in a way that it meets or exceeds expectations and requirements in the organisation and external regulations.
• Handle NCRs and CAPAs.
• Drive improvements in the QMS processes of materials qualification, incoming inspection instruction creation, BOM establishment as well as process development or process validation activities.
• Coordinate with different R&D stakeholders to drive successful QMS audit outcomes in design controls.

Suggested candidate profile

• Diploma or Bachelor’s degree in Engineering, Technical Writing, Communications, or a related field.
• Experience in documentation management, technical writing, or a related role.
• Experience with First Sample Approval (FSA) and BOM cost runs processes.
• Excellent written communication skills with ability to create clear, concise, and easy-to-understand documents.
• Attention to detail by ensuring accuracy and completeness in all documentation.
• Proficiency in document management systems.
• Proficiency in quality systems and standards, along with knowledge of FDA regulations and compliance requirements for medical devices.

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.