Job Description
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NPI Engineer (Process Engineering)
City:  Penang
State: 
Country:  Malaysia
Business Area:  R&D
Department:  NPI Process Validation and Manufacturing Transfer
Employment Type:  Full-time

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

Key responsibilities

Your main responsibilities will include:

  • Collaborate with designers to ensure product designs incorporate Design for Assembly (DFA) principles for enhanced manufacturability.
  • Design and optimize manufacturing processes for efficiency and quality, ensuring compliance with industry standards and regulations.
  • Design and develop prototype jigs and fixtures for sample builds, incorporating Poka Yoke (error-proofing) techniques to prevent defects and ensure high-quality results.
  • Integrate ergonomics and safety considerations into all aspects of process design and development to ensure a safe and comfortable working environment.
  • Perform risk assessments for new processes and implement measures to mitigate identified risks.
  • Collaborate with the Equipment Development & Automation team to define Process Input Requirements (PIR).
  • Conduct feasibility studies, Design of Experiments (DOE), and Process Capability Studies (PCS) to identify optimal process windows that ensure consistent product quality.
  • Provide technical support and troubleshooting for process-related issues.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

  • Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
  • Experience in process engineering or NPI within a manufacturing or R&D environment.
  • Experience with semi-automated manufacturing equipment and electro-mechanical systems is a plus.
  • Familiarity with tools and techniques like Design for Assembly (DFA), Poka Yoke, FMEA (Failure Mode and Effects Analysis), and DOE (Design of Experiments).
  • Strong understanding of various manufacturing processes (e.g., assembly, ultrasonic, UV gluing & curing, and testing & inspection).
  • Proficiency in quality systems and standards, along with knowledge of FDA regulations and compliance requirements for medical devices.
  • Excellent problem-solving and analytical skills.
  • Effective communication and collaboration skills.

 
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.
 
 

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.