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

This position reports to the Senior Manager, Product Engineering. If you are from medical device industry with experience in Design Control and management skills, this position would be suitable for you.

Key responsibilities

• Main tasks:
  • Identify and meet Design Control Engineering goals through strategies to solve problems, improve conditions and coordinate activities setup, process flow and implementation.
  • Manage day-to-day activities of personnel whose activities include under Design Control Engineering. Continuously evaluate team progress through team’s performance review.
  • Estimate costs, resources, and time required to implement the organisation's annual Product Engineering goals and monitor product engineering activities performance, capacity, its setup for research, development, and technical assignments to meet targets.
  • Support team in design control documentations; create, review and approve documents required for New Product Development and Life Cycle Management projects.
  • Support team in the way of working alignment across Solutions and supporting functions for good documentation practice in design control and product document matrix activities.
  • Initiate or provide coaching and facilitation for Change Handlers/Project Managers in relation to design control documentation strategies and activities planning.
• Supporting tasks:
  • Lead to support the review and update of relevant QHBs and R&D documentation to ensure alignment and compliance with regulatory and Ambu requirements
  • Lead to initiate or support design changes in Ambu system according to procedures and are reviewed and approved according to regulatory and Ambu requirements.
  • Support R&D coordination for internal and external audits.
  • Support and mentor R&D Engineers, Executives and Peers Management.

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:

• Masters or Bachelor's Degree in Mechanics / Material or equivalent Engineering and find it easy to understand challenges in other professional areas.
• Minimum 5 years' experience in product engineering environment and how to ensure a stable and reproducible assembly manufacturing processes. Experience with quality system and quality engineering.
• He / She has relevant experience preferably from Medical Device industry, including Design Control practices and Design Changes implementation.
• Open mind for new technologies, sharing knowledge and experience, work processes and to work with other cultures. Team player and drives with high sense of urgency. Good communication skills in English and can express oneself.

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.