Liming Wang

• Systems engineering lead in hardware engineering, involved Immunoassay (IA) projects from Development, VAVE, Production, FSE, and SQE. Closely worked with QA and regulatory to minimize technical risk and safety risk. • IA hardware investigation team leader in systems engineering, collected and analyzed data from daily dispatch list, production DPU, installation quality, Hard Stops, field service records for IA instruments. Completed failure analysis reports, and PLRAs, implemented countermeasures or field actions. • Exploring and using new technologies in IA instruments to improve reliability or reduce cost. • Led urgent projects to solve obsolescence issue and avoid production line down. • Responsible for updating IA instrument requirements, checking design inputs/output, facilitating FMEAs and completing verification processes.

• Figured out requirements for next generation Eeva Scope with both dark field and bright field functions, then completed design. Worked with production to assembly multiple prototypes. Successfully completed internal verification tests and external clinical validation tests. • Redesigned optical lens system of Evan Scope to solve the objective degradation issue. • Collaborated with Imatest to design SFR microscope target to quantify imaging quality of Eeva Scope.

• Established UMIC from scratch, which is to utilize technologies from Otsuka Electronics, Wantai, and Daan Gene, and to design and produce chemiluminescence immunoanalyzers. Recruited employees and trained engineers, negotiated product requirements and user needs, set collaborations with parent companies for instrument development and reagent development. • Managed multiple collaboration projects by checking critical milestones, solving technical issues, reducing risks, reviewing designs, and setting up production. Five prototypes had been assembled in China with 49 motors, 105 sensors and more than 3000 parts per instrument within two years. • Led quality and regulatory teams to complete all CFDA required documents of requirements, design history files, characterizations, verifications, and validations. Started clinical trials for instrument and related reagent in five hospitals. • Led the medical device innovation campaign in Xiamen, and UMIC won 8 million RMB (about 1.3 million USD) funding from city to build Xiamen Medical Device Innovation Center.

• Successfully designed and built optical tweezers for detecting single molecule as well as measuring DNA molecular length, stretching force and surface binding kinetics. • Designed and fabricated multichannel fluorescence microscope, which tracks DNA enzymatic reaction with single molecule detection. • Developed and built electrochemistry detection system, which measures DNA enzymatic reaction through the interaction of electrodes and biomolecules. • Integrated photon counting module into confocal microscope for detecting small volume chemiluminescence reaction.

• Started the Intel Integrated Raman Bioanalyzer (IRBA) project for immunoassay detection with SERS nanoparticles. Completed the optical, mechanical, and electric design and system integration with simulation and modeling tools. • Multiple systems were assembled for assay development and instrument verification. The instruments had premarket submission of FDA 510(K). • Received Intel Recognition Award for IRBA project.

• As the optical engineer lead, completed all optical related designs for Rugby 100, 100LR and 200 rotating lasers, which included system modeling, optical component design, beam propagation, tolerance and accuracy analysis, optical power distribution, verification and validation, and production instruction based on Leica Innovation Process procedures. • As the laser safety officer and product safety officer in Grand Rapids facility, I was not only in charge of R/D and production laser safety, but also responsible for laser classification and product safety documentation based on FDA laser safety regulations and CE product safety regulations.