3931 Kembery Drive
Northbrook, IL 60062
Job Objective To use my abilities and skills as a Software Validation Engineer to fill position with company seeking experienced and dedicated employee.
Summary Of Qualifications:
- Remarkable experience with FDA Design Control regulations, GUI, automated testing tools
- Profound knowledge of software verification and validation approaches
- Steep knowledge of regulations and software lifecycle approaches
- Solid understanding of scripting and programming along with software Test Tools
- Proficient with Labview, C++, CSystem Verilog, Java, Perl, object oriented constructs, Modelsim simulators, and System C
- Expert at QSR’s, ISO 13485, 21 CFR 11, GAMP, SDLC methodologies, and ITIL
- Familiarity with software lifecycle in a regulated environment (ISO9000/FDA)
- Ability to manage with employees and external business contacts
- Superior analytical and organizational skills
- Excellent presentation and communication skills
Software Validation Engineer, August 2005 – Present
PDS Tech, Northbrook, IL
- Evaluated product requirement and outlined specifications and test scripts.
- Conducted validation activities, general system testing and stability testing.
- Verified test configurations and aided in peer reviews of requirements, design specifications, validation plans and test scripts.
- Coordinated with project validation and advancement personnel.
- Conducted manual test script.
Software Validation Engineer, May 2000 – July 2005
KCI, Northbrook, IL
- Suggested improvements to software validation processes.
- Assured documentation met quality standards as well as completeness of software validation records.
- Carried out validation plan and methodology for validation.
- Interpreted test specifications, plans, cases and scripts.
- Imparted expertise in evaluation of deliverables across the product lifecycle.
Bachelor’s Degree in Computer Sciences, El Centro College, Dallas, TX