- 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
Please send your resume to email@example.com.
Only shortlisted candidates will be notified.