Summary
We are an innovative medical technology company developing smart devices that use advanced semiconductors and software to deliver digital treatments, aiming to reduce reliance on traditional drugs. Our top-tier R&D team and strong global regulatory strategy have earned us attention in multiple markets.
Responsibilities
- Review hardware specs and ensure compliance with medical standards.
- Lead process validation activities (DQ/IQ/OQ/PQ)
- Plan and run functional and reliability tests (ISO 13485, IEC 60601, FCC, etc.).
- Conduct ALT, HALT, and stress testing for product lifecycle development (DHF, DMR)
- Coordinate third-party labs for testing and certification.
Requirements
- Bachelor’s in EE, ME, Biomed, or related field.
- 8+ years in hardware quality and verification; 5+ years in medical devices.
- Skilled with lab tools (oscilloscope, spectrum analyzer, EMC/ESD/RF tests).
- Basic scripting (Python/LabVIEW) is a plus; good English communication skills.
- Able to travel domestically and internationally to suppliers and manufacturers.
Post Time｜2025/09/11
