(Senior) V&V Engineer

岗位职责
1、Lead the planning, development, and execution of V&V activities for medical software in compliance with regulatory standards (e、g、, NMPA, FDA, ISO 13485);
2、Develop and maintain V&V protocols, test plans, and test cases based on software requirements and design specifications;
3、Perform risk analysis and ensure traceability of requirements through the V&V process;
4、Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure comprehensive test coverage and timely issue resolution;
5、Conduct software testing to identify defects and ensure software reliability and performance;
6、Document and report test results, defects, and corrective actions in a clear and concise manner.

岗位要求
1、Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field;
2、Minimum of 5 years of experience in software verification and validation in the medical device industry;
3、Good communication skills in English, both Oral and Written, is a MUST-HAVE;
4、Strong knowledge of regulatory requirements and standards for medical software (e、g、, FDA 21 CFR Part 820, ISO 13485, IEC 62304);
5、Proficiency in software testing methodologies, tools, and frameworks、 Knowledge of testing on Windows is a must;
6、Excellent problem-solving skills and attention to detail;
7、Experience with automated testing tools and scripting languages is a plus.