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R&D Engineer
В офисеПолная занятостьHardware EngineeringMedical Device
Seeking an R&D Engineer to design and develop innovative neurointerventional medical devices. Responsibilities include verification testing, design control, documentation (DHF/DMR), and manufacturing transfer. Requires a degree in Mechanical or Biomedical Engineering, SolidWorks proficiency, and knowledge of ISO 13485/FDA regulations.
Обязанности
- Design and develop neurointerventional medical devices
- Plan and execute verification tests for prototypes and products
- Prepare product documentation (DHF and DMR)
- Analyze test results and write engineering reports
- Ensure design control compliance with Quality and Regulatory teams
- Lead design transfer and support manufacturing transitions
Требования
- Bachelor's degree in Mechanical or Biomedical Engineering (GPA 85+)
- 2-5 years of relevant engineering experience
- Full professional English proficiency
- Ability to work in a team and strong communication skills
Будет плюсом
- Medical device industry experience
- Knowledge of ISO 13485 and FDA 21 CFR 820
- Proficiency in SolidWorks