Senior NPI Engineer (Process Engineering)

Ambu; Seberang Perai; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Professional development opportunities

Employee benefits

International head office

Job summary

Ambu A/S in Penang, Malaysia, is seeking an NPI Engineer/Senior NPI Engineer to support new product introduction and process development within the Ambu Global Hub. The role collaborates with R&D to incorporate DFM/DFA principles into designs and to optimize manufacturing processes for quality, efficiency and cost targets.

You will design fixtures, apply Poka-Yoke concepts, and work with the Equipment and Automation team to define equipment specs.

Qualifications

• Bachelor's or Master's degree in Mechanical/Mechatronics/Biomedical Engineering أو related discipline.
• Experience in NPI, Process Engineering, Manufacturing Engineering or Product Industrialization.
• Experience in medical device manufacturing is advantageous.

Responsibilities

• Support new product industrialization from concept through production launch.
• Collaborate with R&D to apply DFM/DFA principles to 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 fixtures and process aids for prototype and production builds.
• Apply Poka-Yoke concepts to reduce process variation and defects.
• Support IQ/OQ/PQ execution for equipment and processes.
• Drive continuous improvement to improve yield, efficiency and product quality.

Skills

Problem solving

Analytical skills

Stakeholder management

Teamwork

Communication

Multi-project management

Hands-on approach

Education

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

Mechatronics Engineering background

Biomedical Engineering background

Tools

DFM/DFA

FMEA

DOE

Statistical analysis tools

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

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 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.