Senior Medical Device Engineer

4 days ago


George Town, Penang, Malaysia Ambu AS Full time
About the Role

Ambu A/S is a visionary and international workplace seeking an experienced R&D Product Engineer to be based in Malaysia.

Key Responsibilities
  • Lead product design and development of specifications, sourcing materials, and implementing Life Cycle Management projects.
  • Provide technical expertise input and participate in Life Cycle Management verification activities.
  • Initiate or support design changes according to procedures and review them for regulatory compliance.
  • Review and update relevant QHBs and R&D documentation to ensure alignment with regulatory requirements.
  • Lead product test method validation and shelf-life verification.
Requirements
  • Minimum 2-3 years' experience leading projects and documenting results.
  • Added advantage if you have experience from the Medical Device industry, including Design Control and mass production.
  • Capable of understanding technical details and ensuring optimal implementation of design changes.
  • Excellent interpersonal communication, organizational, coordination, and problem-solving skills.
  • Proficient in written and spoken English at negotiation level.


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