Job Description :
Location: Sylmar, CA 91342
Duration: 6+ Months
Job Description:
Reviews technical documentation such as requirements specification, design specifications, schematics, manuals, etc…
Provides recommendations for verification and validation strategy of R&D software.
Provides guidance on software risk assessment, analysis, and mitigation.
Writes verification and validation plans, protocols, and reports for R&D software.
Execute verification and validation testing.
Investigates/troubleshoots verification and validation problems for equipment, software, and/or performance processes.
Conducts statistical analyzes of test results and process anomalies.
Conducts code review on C and Python code languages
Reviews, analyzes, and provides recommendations for verification and validation test data.
Provides guidance on resolving deviations associated with verification and validation activities.
Communicates verification and validation strategy and results with engineers and management alike.
Basic understanding of instrumentation use, such as Function Generators, Oscilloscopes, Multimeters, etc.
Qualifications:
Bachelors of Science in Electrical Engineering, Computer Engineering, Robotics/Automation Engineering, or similar degree required.
ASQ CQE or CSQE certifications preferred.
Minimum 2-5 years of experience in software verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.
Medical device (Class III) experience strongly preferred.
Experience with NI LabWindows/CVI and Python IDEs desired.
Familiar with cGMP, Title 21 CFR Part 11, Title 21 CFR Part 820, ISO 13485.