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.