Systems Engineer & Biomedical Engineer - Biotech Resume Search
Systems Engineer & Biomedical Engineer - Biotech Resume Search
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Systems Engineer & Biomedical Engineer Resume


Desired Industry: Biotech SpiderID: 78204
Desired Job Location: San Jose, California Date Posted: 10/12/2016
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 70000
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Masters Willing to Relocate: No


Objective:
Highly analytical, performance-focused, and results-driven professional, offering comprehensive

experience in data structure, software engineering, core laboratory practices, and experimental design.

Equipped with expertise in integrating system components to ensure efficiency and accuracy of

experimental and statistical analysis of data. Effective at developing processes and analyzing

algorithms, while maintaining understanding of the science and software within biomedical device fields.

Articulate communicator; fluent in Chinese.



Experience:
ROCHE MOLECULAR SYSTEMS | PLEASANTON, CA, USA
SYSTEMS ENGINEER, Contract Position Mar 2015–Present
- Generate technical documents used for regulatory submission, which include test plans, protocols,

standard operarating procedures, and summary reports.
- Thoroughly assess testing results for applicability, validity, and compliance with the product

requirements.
- Conduct in-depth failure modes and effects analysis (FMEA) to determine and mitigate risk of

product misuse; as well as system-level verification and validation of devices to guarantee client

usability for applications.
- Hold responsibility in verifying the system’s core software functionalities and perform testing

of over six major software versions and over three assay scripts for cobas Liat analyzer.
- Administer the overall system reliability for cobas Liat analyzer and configuration and risk

management as well as technical requirements.
- Impart knowledge to a team of system engineers on laboratory configuration and system workflows.
- Write the cobas Liat installation manual as support to the internal installation and operation

qualification.
Career Highlights:
> Conceptualized and actualized a feasibility and ad hoc/debug tests for the validation and

development of reagents and hardware system components to guarantee reliability of usage.
> Successfully implemented process improvements to enhance workflows and project timeline

efficiency.
> Provided expert oversight to the test development and system verification for the cobas® Liat®

analyzer configuration 3.0 and 3.1 software update.

BD BIOSCIENCES | SAN JOSE, CA, USA
SYSTEMS VERIFICATION SPECIALIST, Contract Position Mar 2014–Mar 2015
- Maintained active involvement in system verification and characterization testing used for flow

cytometers including a combination of hardware, reagents, and software on assigned program.
- Analyzed data through the use of statistical tools for clinical/research diagnostic products and

systems; interpreted results of system verification studies.
- Encoded defects and product incident reports or requests for modifications and handled the

regression testing for optimum product quality.
- Adhered to quality systems regulations and ISO guidelines for design control.
- Established a safe work environment and provided recommendations on safety compliance.
- Rendered support in preparing information for design documentation and technical design reviews.
Career Highlights:
> Spearheaded the plasma count stability verification test and created test protocols and final

report.
> Demonstrated expertise in troubleshooting various BD instruments; provided feedback to the Design

Team regarding product performance; as well as developing IVD and CE-IVD molecular

instrumentation/platform.


OTHER EXPERIENCE

UNIVERSITY OF KANSAS MEDICAL CENTER-DEPARTMENT OF PATHOLOGY | KANSAS CITY, KS, USA
RESEARCH ASSISTANT Mar 2012–Dec 2012

KANSAS STATE UNIVERSITY-DEPARTMENT OF ANIMAL SCIENCES | MANHATTAN, KS, USA
GRADUATE RESEARCH |TEACHING ASSISTANT Aug 2009–Dec 2011

TAIPEI MEDICAL UNIVERSITY-DEPARTMENT OF NEUROSURGERY | TAIPEI, TAIWAN
CLINICAL RESEARCH ASSOCIATE Aug 2007–Jul 2009

TAIPEI VETERANS GENERAL HOSPITAL-DNA RECOMBINANT LAB | TAIPEI, TAIWAN
RESEARCH ASSOCIATE INTERNSHIP Mar 2007–Jul 2007


Education:
MASTER OF SCIENCE IN ANIMAL SCIENCES, WITH FOCUS IN ANIMAL PHYSIOLOGY
Kansas State University | Manhattan, KS

BACHELOR OF SCIENCE IN ANIMAL SCIENCE
Chinese Culture University | Taipei, Taiwan

BACHELOR OF SCIENCE IN COMPUTER SCIENCE, IN PROGRESS: 2017
Oregon State University-Online | Corvallis, OR


Skills:
Research and Development
Quality System
Biomedical Engineering
Systems Engineering
Requirements Analysis
Specification Development
Regression and Negative Testing
Medical Device Engineering


Additional Information:
TECHNICAL ACUMEN

Programming Languages: C, C++, Python, SQL JMP, SAS
Software: Minitab, JMP Software, SAS, MetLab, HP Application Lifecycle Management (HP ALM)
Microsoft Applications: Word, Excel, PowerPoint
Others: Accuri (FACSVia Clinical & UDP), Calibur (CellQuest Pro and Multitest)


RESEARCH PROJECT

Li, S. (2011). Identification of angiopoietin-like protein 4 receptor. Kansas State University, KS.

Li, S. (2011). Volatile fatty acid effects on angiopoietin-like protein 4 concentration in ruminant

tissue of cattle. Kansas State University, KS.

PRESENTATION

Li, S. (2011). Effects of volatile fatty acid infusions on angiopoietin-like protein 4 concentration in

plasma and ruminal papillae of cattle. Animal Science National Conference, New Orleans, LA.

THESIS

Li, S. (2011). Angiopoietin-like protein 4 in bovine physiology. (Master’s Thesis). Retrieved from K-

state research exchange. (http://hdl.handle.net/2097/13107).

JOURNAL

Li, S., Yuan, L., K. Mamedova, G.B., Penner, M., Oba, K.A., Beauchemin, B., Bradford, J. (2014). High-

grin diets suppress ruminal tissue abundance of angiopoietin-like protein 4 in cattle. J. Anim. Sci, 92

(9), 4077-85.


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