Senior NPI Process Engineer — Medical Devices

Ambu A/S; Malaysia; On-site; MYR 180,000 - 240,000; Full time

Job summary

Ambu A/S in Penang, Malaysia, seeks a Senior NPI Engineer to drive process development and product industrialization. You will collaborate with R&D to implement DFM/DFA, design and optimize manufacturing steps, and support production launches from concept to ramp.

The role covers tooling and equipment development, process validation, risk management, and cross-functional collaboration with Quality, Manufacturing, Supply Chain, and Global Project Teams.

Qualifications

• Bachelor's or Master's in Mechanical/Mechatronics/Biomedical Engineering.
• Experience in NPI, Process Engineering, Manufacturing Engineering, or Product Industrialization.
• Experience in medical device manufacturing is an advantage.

Responsibilities

• Support new product industrialization from concept through production launch.
• Collaborate with R&D teams to incorporate DFM and DFA principles into product designs.
• Develop and optimize manufacturing processes to achieve quality, efficiency, and cost targets.
• Define critical process parameters and establish process controls.
• Design, develop, and evaluate manufacturing jigs, fixtures, and process aids for prototype and production builds.
• Apply Poka-Yoke concepts to reduce process variation and prevent defects.
• Work with Equipment and Automation teams to define PIR and equipment specs.
• Support IQ, OQ, and PQ execution for manufacturing equipment and processes.
• Establish robust process windows to ensure quality and regulatory compliance.
• Conduct process risk assessments and FMEA to identify manufacturing risks.
• Investigate process issues and implement corrective actions.
• Drive continuous improvement to improve yield, efficiency, ergonomics, and quality.
• Collaborate with Quality, Manufacturing, Supply Chain, Technical, Process and Global Project Teams on NPI projects.
• Provide technical support during pilot builds, process transfers, and production ramp-up.

Skills

Problem solving

Analytical skills

Multi-project management

Communication skills

Teamwork

Education

Bachelor's or Master's in Mechanical/Mechatronics/Biomedical Engineering

Tools

Ultrasonic welding

UV bonding and curing

Testing and inspection systems

Semi-automated equipment

DFM/DFA

FMEA

DOE

Process capability studies

Statistical analysis tools

Lean manufacturing

Job description

Ambu A/S in Penang, Malaysia, seeks a Senior NPI Engineer to drive process development and product industrialization. You will collaborate with R&D to implement DFM/DFA, design and optimize manufacturing steps, and support production launches from concept to ramp.

The role covers tooling and equipment development, process validation, risk management, and cross-functional collaboration with Quality, Manufacturing, Supply Chain, and Global Project Teams.