Working with R&D, quality assurance and manufacturing teams to develop reliability requirements (including requirements cascade), develop and implement comprehensive reliability test plans for IVD medical devices that align with product development and production processes.
Developing reliability plans and requirements, leading and facilitating Design Failure Mode and Effects Analysis (DFMEA).
Designing and developing test methods and fixtures to assess the performance and durability of IVD devices.
Writing test protocols, training personnel on test procedure, analyzing data and creating final reports.
Conducting reliability tests and documenting results, including environmental, lifecycle, and accelerated aging tests, to evaluate product performance under different conditions and in compliance with relevant regulatory standards and guidelines.
Analyzing test results and providing detailed reports, identi...