Senior NPI Engineer I (Process Engineering)

Ambu; Malaysia; On-site; MYR 60,000 - 120,000; Full time

Job summary

Ambu A/S in Penang, Malaysia, is seeking a Senior NPI Engineer I to drive process development for new products from concept through production launch. You will collaborate with R&D to apply DFM/DFA, design robust processes, and ensure quality, efficiency and cost targets are met.

The role involves risk assessment, process validation, and cross-functional teamwork during pilot builds and ramp-up. Ambu offers an international, fast-paced environment with opportunities for development and

Qualifications

• Bachelor's or Master's degree in Mechanical/Mechatronics/BME or related field.
• 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 to production launch.
• Collaborate with R&D to integrate DFM/DFA into designs.
• Develop and optimize processes to meet quality, efficiency and cost targets.
• Define critical parameters and establish process controls.

Skills

Assembly processes

Ultrasonic welding

UV bonding and curing

Testing and inspection systems

Semi-automated manufacturing equipment

DFM/DFA

FMEA

DOE

Process Capability Studies

Statistical analysis tools

Lean Manufacturing principles

Education

Bachelor's or Master's Degree in Mechanical Engineering, Mechatronics Engineering, Biomedical Engineering, or related discipline

Job description

Senior NPI Engineer I (Process Engineering)

City: Penang Country/Region: Malaysia State: Business Area: R&D Department: NPI Process & Automation Employment Type: Full-time Req ID: 10514

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 (Note: original text had a space between i and >)
  • Process Capability Studies
  • Statistical analysis tools
  • Lean Manufacturing principles

Personal Competencies

• 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.

For more information, please visit ambu.com or follow us on LinkedIn .