NPI Engineer – Medical Device Process Innovation

Ambu A/S; Malaysia; Hybrid; MYR 112,000 - 201,000; Full time

Job summary

Ambu A/S is seeking an NPI Engineer/Senior NPI Engineer for its Process Engineering team based in Ambu Global Hub, Penang, Malaysia. You will support new product industrialization from concept to production launch and collaborate with R&D to apply DFM/DFA principles.

Responsibilities include developing manufacturing processes, defining process parameters, tooling development, and supporting validation activities to ensure quality and regulatory compliance.

Qualifications

• Bachelor's or Master's degree in relevant engineering
• Experience in NPI or process/manufacturing engineering
• Experience in medical device manufacturing is an advantage
• Strong problem solving and analytical abilities

Responsibilities

• Support product industrialization from concept to production launch
• Collaborate with R&D to apply DFM/DFA in designs
• Develop and optimize manufacturing processes to meet quality and cost targets
• Define critical process parameters and establish process controls
• Design, develop and evaluate jigs, fixtures, and process aids
• Apply Poka-Yoke concepts to reduce defects
• Support IQ/OQ/PQ execution for equipment and processes
• Conduct risk assessments and FMEA to mitigate risks and drive CAPA
• Collaborate with Quality, Manufacturing, Supply Chain on NPI projects
• Support pilot builds, process transfers and ramp-up activities

Skills

NPI experience

Process engineering

Manufacturing engineering

Problem solving

Analytical skills

Communication skills

Stakeholder management

Teamwork

Education

Mechanical/Mechatronics/Biomedical Eng degree

Tools

DOE

FMEA

Statistical analysis

Lean Manufacturing

Job description

Ambu A/S is seeking an NPI Engineer/Senior NPI Engineer for its Process Engineering team based in Ambu Global Hub, Penang, Malaysia. You will support new product industrialization from concept to production launch and collaborate with R&D to apply DFM/DFA principles.

Responsibilities include developing manufacturing processes, defining process parameters, tooling development, and supporting validation activities to ensure quality and regulatory compliance.