BME JOB FINDER

11/13/2014
Rockville, MD

Position Desired

Biomedical Engineering
Anywhere in the U.S.
Yes

Resume

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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