V&V engineer

1. Verification Strategy and Documentation Development Develop verification strategies and documentation systems based on product requirements, risk analysis (FMEA), industry standards (ISO 15197, ISO 10993, YY/T), and regulatory requirements. Prepare the V&V master plan, verification plans, validation protocols, and test cases. Manage the entire verification process, address test deviations, implement CAPA actions to ensure closure, and deliver comprehensive verification reports. Provide data support for product design transfer, NMPA / MDR registration, and CEP clinical evaluations, ensuring all documentation complies with GMP requirements. 2. Multi-dimensional Design Verification for CGM Products - Sensor Electrochemical Validation: Evaluate electrochemical performance, sensitivity, baseline noise, signal drift, accuracy under interstitial fluid simulation, response time, and sensor lifetime; assess interference of temperature and humidity on sensor signals. - Implant Insertion Component Mechanical Validation: Validate insertion resistance, needle detachment force, patch peel strength, bend resistance, simulated skin implantation, edge lift prevention, and wear reliability. - Transmitter System Validation: Test Bluetooth RF communication, overall power consumption, battery life, environmental reliability (temperature, humidity, drop, vibration), IP protection, and reliability of button and snap mechanisms. - System-level Validation: Validate overall glucose accuracy, algorithm integration, abnormal scenario simulations, and software functionality. 3. Test Fixture Management and Failure Analysis Maintain CGM verification test benches, including electrochemical workstations, tensile/compression testers, environmental chambers, and skin simulators. Conduct sample testing and retain original records. Perform failure analysis on non-conforming samples to identify root causes in electrochemistry, structure, hardware, or manufacturing processes. Organize issue reproduction, generate failure analysis reports, and collaborate with R&D, chemistry, and structural teams to drive resolution. Manage verification samples, reference materials, and dedicated fixtures. 4. Internal and External Verification Project Management Coordinate internal lab verification activities. Interface with third-party testing organizations to define test item lists, submit samples, track project progress, and review test reports. Clearly distinguish between in vitro simulation, ex vivo tissue, and animal study boundaries. Manage non-clinical verification data to support clinical evaluation documentation. 5. Change Verification and Risk Control Participate in product design change assessments, identify affected areas, and conduct regression testing. Contribute to DFMEA/PFMEA reviews by adding necessary verification items based on identified risks. Support internal audits, system inspections, and pre-registration site inspections to ensure traceability of verification activities. 6. Cross-functional Collaboration and NPI New Product Introduction Collaborate with R&D, Quality, Regulatory, and Manufacturing teams. Participate in EVT/DVT/PVT phase reviews. Track verification activities during new product introduction. Identify risks in incoming materials and prototype versions, provide verification recommendations, and support reproduction testing for customer complaints and field failures. 7. Testing Capability Development Optimize dedicated CGM verification fixtures and tools. Build a standardized library of verification methods, refine internal work instructions, and continuously improve verification efficiency.