Shumin Cheng currently serves as Engineer V at Quidel, formerly known as Alere Inc., where she leverages her extensive expertise in statistics and applied mathematics to drive innovation in diagnostic solutions. With a robust background in sampling, descriptive and inferential analyses, and predictive analytics, Shumin...
Shumin Cheng currently serves as Engineer V at Quidel, formerly known as Alere Inc., where she leverages her extensive expertise in statistics and applied mathematics to drive innovation in diagnostic solutions. With a robust background in sampling, descriptive and inferential analyses, and predictive analytics, Shumin plays a pivotal role in the design and execution of experiments that enhance product reliability and safety. Her proficiency in tools such as MATLAB, Python, and Minitab allows her to conduct sophisticated data analyses that inform critical decisions regarding product performance and risk management.
At Quidel, Shumin is actively involved in key projects focused on post-market surveillance (PMS) and periodic safety update reports (PSUR). Her work in benefit-risk analysis ensures that the products not only meet regulatory standards but also deliver maximum value to end-users. By employing techniques like Failure Mode and Effects Analysis (FMEA) and Six Sigma methodologies, she systematically identifies potential risks and implements corrective actions to mitigate them, thereby enhancing overall quality assurance.
Shumin's expertise in mechanical engineering and materials science, combined with her knowledge of statistical process control (SPC) and design of experiments, positions her as a leader in the development of cutting-edge diagnostic technologies. Her commitment to data automation and simulation further streamlines processes, enabling her team to respond swiftly to evolving market demands. Through her contributions, Shumin Cheng exemplifies the integration of rigorous statistical analysis with practical engineering solutions, ultimately advancing Quidel’s mission to improve patient outcomes through reliable diagnostic testing.
