Job Description

Ambu A/S is currently looking for a Staff NPI Engineer (Process Engineering) to be based in Penang, Malaysia.

The Staff NPI Process Engineer is responsible for developing and industrializing electronics, PCBA, box-build, and electromechanical manufacturing solutions for new medical devices. Depending on business needs, the role may lead industrialization activities at supplier and contract manufacturer sites or be part of the NPI team responsible for developing, qualifying, and transferring manufacturing lines within Ambu production facilities.

This position requires extensive travel to supplier and contract manufacturer locations during development, qualification, and production ramp-up phases.

Key responsibilities

Your main responsibilities will include:

• Lead the industrialization and manufacturing readiness of PCBA, box-build, and electromechanical products at supplier and contract manufacturer sites.
• Drive DFM, DFA, DFT, and error-proofing principles to establish robust and scalable manufacturing processes.
• Serve as the primary technical interface with suppliers and contract manufacturers, driving technical reviews, risk assessments, and issue resolution.
• Lead DOE, PFMEA, Process Capability Studies (PCS), process validation (IQ/OQ/PQ), and manufacturing risk assessments.
• Support equipment qualification, FAT, SAT, pilot builds, and production ramp-up activities.
• Challenge and improve supplier manufacturing processes, process controls, inspection methods, and validation strategies.
• Lead troubleshooting, root cause investigations, and continuous improvement initiatives related to quality, yield, reliability, and productivity.
• Ensure manufacturing processes are properly documented, validated, and maintained in compliance with Ambu Quality System and regulatory requirements.
• Partner with R&D, Supplier Quality, Manufacturing Transfer, Automation, and Operations teams to ensure successful product launch and manufacturing stabilization.
• Drive timely closure of NCRs, CAPAs, technical actions, and manufacturing-related quality issues.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Bachelor's Degree or higher in Engineering (Mechanical, Manufacturing, Mechatronics, Electronics, Industrial, or related discipline).
• Minimum 8 -10 years of experience in electronics, PCBA, EMS, or advanced manufacturing environments.
• Experience working directly with contract manufacturers and suppliers in product industrialization and manufacturing transfer.
• Strong experience in PCBA, electronics assembly, and box-build manufacturing processes.
• Experience with supplier industrialization, manufacturing transfer, and production ramp-up.
• Practical knowledge of DOE, PFMEA, SPC, PCS, IQ/OQ/PQ, and process validation methodologies.
• Experience with FAT, SAT, equipment qualification, and pilot build activities.
• Strong troubleshooting and root cause analysis skills.
• Experience in medical device, EMS, electronics, semiconductor, or other regulated industries.
• Excellent communication and stakeholder management skills.
• Willingness to travel extensively to supplier sites.

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.