高级测试工程师

61 Lead the planning, development, and execution of V&V activities for medical software in compliance with regulatory standards (e.g., NMPA, FDA, ISO

13485).

61 Develop and maintain V&V protocols, test plans, and test cases based on software requirements and design specifications.

61 Perform risk analysis and ensure traceability of requirements through the V&V process.

61 Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure comprehensive test coverage and timely issue resolution.

61 Conduct software testing to identify defects and ensure software reliability and performance.

61 Document and report test results, defects, and corrective actions in a clear and concise manner.

Requirements:

61 Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

61 Minimum of 5 years of experience in software verification and validation in the medical device industry.

61 Good communication skills in English, both Oral and Written, is a MUST-HAVE.

61 Strong knowledge of regulatory requirements and standards for medical software (e.g., FDA 21 CFR Part 820, ISO 13485, IEC

62304).

61 Proficiency in software testing methodologies, tools, and frameworks. Knowledge of testing on Windows is a must.

61 Excellent problem-solving skills and attention to detail.

61 Experience with automated testing tools and scripting languages is a plus.