Job Responsibilities
1. Conduct full-cycle testing for medical devices, including functional, performance, reliability and regression testing, to ensure products meet design specifications and clinical usage standards.
2. Analyze product test requirements, develop test plans, design standardized test cases, and complete testing tasks on schedule.
3. Discover, log, track and verify defects strictly, ensuring all quality risks are resolved before product release.
4. Execute all testing activities in accordance with medical regulatory standards and company QMS to ensure product compliance and market qualification.
5. Organize test data analysis, compile formal test reports, and provide objective quality assessment for project delivery and product approval.
6. Continuously improve testing procedures and methods to enhance testing efficiency and reduce clinical and after-market quality risks.
Job Requirements
1. Bachelor degree or above in Electronics, Automation, Biomedical Engineering or related majors.
2. Familiar with medical device development process and QMS quality system requirements.
3. Proficient in test case design, defect management and full product testing procedures.
4. Basic knowledge of medical device regulations, including ISO13485, FDA or NMPA compliance requirements.
5. Possess rigorous logical thinking, detailed problem analysis ability and stable execution capability.
6. Good written and verbal communication skills, able to cooperate efficiently with R&D, engineering and project teams.
