Design Control Engineer

Ambu is currently looking for a Design Control Engineer to be based in Penang, Malaysia.

This position reports to the Head of Engineering. If you are from medical device industry with experience in test & verification, this position would be suitable for you.

Key responsibilities

• Process document ownership / expertise for Life Cycle Management (LCM) activities with in-depth understanding of Device Master Record and Design History File from Design Control perspective.
• Ensure design control process and documentation alignment with stakeholders in design changes for LCM.
• Review documents and sign-off on Design Change Order, SCO's etc. for LCM activities specified in Quality Management System.
• Have good overview of Design Change Request 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.

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 :

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.

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