Biomedical Engineer
Highly-motivated Biomedical Engineer with more than five years of extensive experience in the development, integration, and interoperability testing of a clinical diagnostic device. A listed inventor of US Patent Application No: 2013/0315.780 Diagnostic systems and instruments.
Professional Experience
1. Medical Device Developer June 2008 - Present
Systems Integration
Wellstat Diagnostics
Key achievements
• Design a clinical diagnostic system that contains a self-contained multi-panel assay cartridge and an instrument
• Develop, automate, and optimize methods for executing clinical assays in the cartridge with the instrument
• < 2%CV
• +95% Sample Recovery
• 99.7% Wash Efficiency
• Reduce the carryover within a cartridge run and between cartridge runs
• < 100ppm with 250,000 magnetic beads per 26uL sample
• Design and develop incubator components for the instrument
• Develop a method to detect cartridges at different initial temperatures
• Develop a method to reduce the variability between cartridge runs due to the difference in initial cartridge temperature
• Within 15˚C and 32˚C matrix, the variability was reduced +/- 0.1˚C
• Assist an engineering team in developing a method for an internal standard
• Evaluate paramagnetic beads with different fluorophores
• Develop and automate a method to measure the internal standard in the cartridge process
• Assist an engineering team in material selection for the instrument hardware
• Improve the performance of the instrument by optimizing the instrument operation
• Flow cell waveform generator bandwidth optimization
• Electrophoresis optimization for improved sample cleaning activities in the cell
• Develop a Quality Control procedure for the diagnostic instrument
• Develop methods to filter defective hardware components before manufacturing
• Assist an assay development team in optimizing reagents by evaluating different formulations in perspectives of carryover and foaming
Responsibilities
• Design and develop components and subsystems of a clinical diagnostic device according to Design Control
• Generate test protocols for experimental studies and write test reports
• Evaluate capability of new designs to meet design requirements
• Identify the root causes of system design problem and resolve the problem
• Conduct technical and design reviews
• Initiate improvements to devices under development
• Design processes and methods for automation of immunoassays
• Perform duties per GMP
• Conduct studies in support of company’s commercialization of a clinical diagnostic device
2. Analyst March 2008 - June 2008
Xceleron Inc [Phase 0/1 Accelerated Mass Spectrometer (AMS)-HPLC Analysis for Pharmacokinetics]
• Execute clinical and non-clinical research analysis on microdosed plasma, urine, and feces samples
• Prepare samples for the accelerated mass spectrometer (AMS) analysis
• Perform AMS analysis for pharmacokinetic (PK) study (absolute availability, mass balance, microdosing, and metabolite profiling)
• Assist with process developments for clinical and non-clinical samples
• Assist Study Director with writing a report for each study
• Write the Standard Operation Procedure (SOP) for laboratory equipments according to GLP and GCP regulations
3. Process Engineer October 2006 - March 2008
Department of Reagent Manufacturing / Tech Transfer
BioVeris Corporation [Leader of Electrochemoluminescence (ECL) Technology]
• Design preventative maintenance schedule for the laboratory equipments in the facility
• Execute performance verification on basic to advanced laboratory equipments
• Troubleshoot laboratory/manufacturing equipments
• Create and revise Standard Operation Procedure (SOP) and Standard Manufacturing Procedure (SMP)
• Purify antigen and antibody prior to the biotinylation and ruthenylation by LPLC and FPLC
• Formulate biotinylated antibody and ruthenylated antigen
• Optimize formulated reagents (Signal vs. Noise Analysis)
• Perform the quality analysis of reagents with HPLC
• Improve t...
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