Staff Design Control Engineer

Country:  Malaysia

Penang, MY

City:  Penang
Business Area:  R&D
Employment type:  Full-time



  • Process document ownership / expertise for Life Cycle Management (LCM) activities with in-depth understanding of DMR and DHF from Design Control perspective.
  • Ensure design control process and documentation alignment with stakeholders in design changes for LCM.
  • Review/ Approve documents and sign-off on DCO's, SCO's etc. for LCM activities specified in Quality Management System.
  • Have technical understanding of the product (but not technically responsible).
  • Have good overview of DCR and product document matrix.
  • Provide coaching and facilitation for Change Handlers in relation to documentation strategy and activity planning.
  • Align the way of working in design changes documentation across Solutions and supporting functions for good documentation practice.





  • Masters or Bachelor's Degree in Mechanics / Material or equivalent Engineering and find it easy to understand challenges in other professional areas.
  • Minimum 3 years' experience in product engineering environment and how to ensure a stable and reproducible assembly manufacturing processes. Experience with quality system and quality engineering.
  • Advantage if he / she has relevant experience preferably from Medical Device industry, including Design Control practice and Design Changes implementation.
  • Open mind for new and sharing knowledge, experiences and work processes. Team player and drives with high sense of urgency.
  • Demonstrates excellent interpersonal communication, organizational, coordination, and problem-solving skills, especially in cross-functional teams.
  • Be proficient in written and spoken English at negotiation level. Good interpersonal skills.
  • Work independently, structured and systematic. Able to work in a cross-cultural team.

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 or follow us on LinkedIn.