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
- Ensure hardware and system compliance with ISO 13485, IEC 60601, and related standards.
- Plan and execute reliability tests (EMC/ESD, thermal, vibration, HALT/ALT).
- Lead design verification, issue tracking, and failure analysis (RCA/CAPA).
- Coordinate third-party labs for product testing and certification.
- Collaborate with R&D, Quality, and Manufacturing to resolve design issues and support NPI.
Requirements
- Bachelor’s in EE, ME, Biomed, or related field.
- 8+ years in hardware verification/testing; 5+ years in medical devices.
- Skilled with lab tools (oscilloscope, spectrum analyzer, vibration/thermal test).
- Familiar with ISO 13485, IEC 60601, FCC, FDA 21 CFR 820.
- Python/LabVIEW scripting is a plus; good English communication; willing to travel.
- Fluent in both English and Mandarin speaking and writing.
Post Time｜2025/10/17
