Product Engineer/Manager


  • Design and develop medical device instrument and in vitro diagnostic device from a lab prototype
  • Define product requirements and specifications to meet applicable medical device regulatory standards to achieve desired functionality
  • Build engineering prototype and ready-to-market prototype
  • Integrate mechanical, electrical and optical components to a fully functional engineering system and estimate the cost of each test
  • Troubleshoot technical issues encountered during instrument design, prototyping and testing


  • Bachelor or Master in Mechanical/Electrical Engineering with at least 5 years’ experience in medical device product design and development
  • Experience in molding, CNC, temperature control, fluorescence detection, and signal processing
  • Expertise in Solidworks and CAD software, including animation
  • Experience in Instrument Design preferred
  • Excellent experience in Design for Manufacturing and Assembly (DFMA) techniques
  • Experience with ISO 13485 / CE / FDA regulations, familiar with Design Control and Design History File Requirements
  • Experience in development of medical devices preferred

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