NPI Engineer (Process Engineering)

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 currently looking for an NPI Engineer/ Senior NPI Engineer for our Process Engineering team to be based in Ambu Global Hub, in Penang, Malaysia.

Key responsibilities

New Product Introduction (NPI) & Process Development

• Support new product industrialization from concept through production launch.
• Collaborate with R&D teams to incorporate Design for Manufacturing (DFM) and Design for Assembly (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.

Tooling, Fixtures & Equipment Development

• Design, develop, and evaluate manufacturing jigs, fixtures, and process aids for prototype and production builds.
• Apply Poka-Yoke (error-proofing) concepts to reduce process variation and prevent defects.
• Work with the Equipment and Automation team to define Process Input Requirements (PIR) and manufacturing equipment specifications.

Process Validation & Qualification

• Support IQ, OQ, and PQ execution for manufacturing equipment and processes.
• Establish robust process windows to ensure consistent product quality and regulatory compliance.

Risk Management & Continuous Improvement

• Conduct process risk assessments and FMEA activities to identify and mitigate manufacturing risks.
• Investigate process issues and implement effective corrective and preventive actions.
• Drive continuous improvement initiatives to improve yield, efficiency, ergonomics, and product quality.

Cross-Functional Collaboration

• Work closely with Quality, Manufacturing, Supply Chain, Technical, Process and Global Project Teams throughout NPI projects.
• Provide technical support during pilot builds, process transfers, and production ramp-up activities.
• Support Life Cycle changes activities between global sites.

Suggested candidate profile

Education & Experience

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

Technical Skills

• Strong understanding of manufacturing processes such as:
  • Assembly processes
  • Ultrasonic welding
  • UV bonding and curing
  • Testing and inspection systems
  • Semi-automated manufacturing equipment
• Familiar with:
  • DFM/DFA
  • FMEA
  • DOE
  • Process Capability Studies
  • Statistical analysis tools
  • Lean Manufacturing principles
• Strong problem solving and analytical skills
• Able to manage multiple projects in a fast-paced NPI environment.
• Effective communication and stakeholder management skills.
• Team-oriented with a proactive and hands-on approach.

Ambu – a visionary and international workplace where your efforts matterAmbu 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.