NPI Engineer (Process Engineering)

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…