Product Development Systems Engineer – Medical Devices and Biotechnology
Customer-oriented multidisciplinary scientist/engineer, with 6+ years of experience across the full product
development lifecycle in the medical device and biotechnology industries. Demonstrated technical and project
leadership across a broad range of scientific and engineering disciplines.
Platform Optimization, Six Sigma & Lean Processes, Requirements Definition, Specification Setting,
Conceptual and Numerical System Modeling, Biochemistry, Design of Experiments, Food and Drug
Administration (FDA) and International Standards Organization (ISO) Medical Device Regulations
Professional Experience
PACIFIC BIOSCIENCES OF CALIFORNIA Menlo Park, CA, 2010-2011
Manufacturing process definition, instrument troubleshooting, and manufacturing process data review.
Senior Systems Engineer, Manufacturing, 2010 - 2011
* Implemented Design for Six Sigma strategies on design processes to reduce build cycle time by 4%.
* Reduced instrument-to-instrument performance variation by at least 10% through implementation of automated
fulidics system qualification strategies on first commercial-launch instruments.
* Defined systems design requirements related to Design for Manufacturability, Assembly, and Serviceability for second-generation instrumentation.
* Reduced time spent reworking instrument by average 3% to 4% through execution of instrument performance
variability study.
* Reduced likelihood of out-of-box failures by 10% defining several new manufacturing processes.
* Improved ease of assembly by manufacturing assembly technicians through implementation of a
troubleshooting guide for machine vision and robotics system.
APPLIED BIOSYSTEMS INC. (A DIVISION OF LIFE TECHNOLOGIES) Foster City, CA, 2009-2010
Designed and verified molecular biology instrumentation.
Senior Systems Engineer, 2009 - 2010
* Led product development and verification and validation efforts to convert existing research use only instrument into first FDA-regulated Class I diagnostic end-point thermocycler. Project was completed on time and on budget.
* Executed and analyzed design efforts to change instrument settings in real-time Polymerase Chain Reaction
(PCR) instrument used in both in-vitro diagnostics and research use only environments. Implemented engineering
changes in a thermal subsystem that improved instrument measurement repeatability by 25%.
* Integrated and led troubleshooting efforts on robotics device from 3rd-party vendor to convert existing real-time PCR instrument into high-throughput version. Integration enabled stated core throughput functionality for the system, and required structured integration efforts.
* Leading international new product development team in activities for the release of new real-time PCR product with innovative optical and thermocycler technologies.
* Planned, designed, and executed experiments to support new patent application.
VENTANA MEDICAL SYSTEMS INC. (A MEMBER OF THE ROCHE GROUP) Tucson, AZ, 2005-2009
Designed and verified In Vitro Diagnostic Devices (IVDD).
Senior Systems Engineer and Team Leader, 2008 - 2009
* Led a small team to deliver complete set of functional requirements 6 months sooner than previous product
development cycles through designing a full functional architecture to define next-generation automated
coverslipping technology.
* Assisted in defining roles and responsibilities for the Systems Engineering organization; advised on strategies and technical, and process matters, as well as training and growth.
* Improved reliability of the coverslipping technology by 6 months through implementation of a Design for Six
Sigma (DFSS) project.
Scientist, 2005 - 2008
* Led verification and validation efforts for a waste capture device for the core product, revenue from core product increased by $750,000 as a result of successful waste capture device launch
* Used Six Sigma and Lean methodologies to track and assess in-field instrument failures, developing strategies to reduce lifetime failure rates of a key fluidic system by 20% or more.
* Fully defined and developed system architecture for novel product; facilitating a...
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