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Software V&V Engineer

Secunderabad, Telangana
Job Code:
  • Medical
  • Manufacturing & Production
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Job Details

GAMP 5 - Good Automated Manufacturing PracticeTIR362007, Validation of Software for Regulated ProcessesGuidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical DevicesGeneral Principles of Software Validation; Final Guidance for Industry and FDA Staff Validation of Automated Process Equipment & Quality System SoftwareExperience in the development of embedded, real-time systems.Knowledge of C/C++ and some familiarity with UML.Experience working in a structured software development environment following a well-defined software development process. Experience with software and system risk analysis (per ISO 14971) including faulttree analysis, software failure mode and effects analysis (FMEA).Knowledge of software issue tracking systemsSome knowledge of scripting languages (e.g. Python, Perl, Lua etc.)Knowledge of CASRE tool for estimation of software reliability is desirableAbility to accurately estimate tasks and track/communicate progress for software verification and validation tasksSkills in personal computer spreadsheet, word processor and engineering tools.Ability to carry out engineering calculations, analysis and problem solving.Ability to make oral presentations at company meetings.Effective oral and written communication skills.Works well with a team.PREFERRED SKILLSExperience with modern software testing tools and methods, including validation of object-oriented systems.Experience with test automation, especially National Instruments LabView and Test Stand. Experience with Requirements Management tools, configuration management tools and embedded software development tools (integrated development environments, debuggers, etc.).Experience with Field-Programmable Gate Arrays (FPGAs), the Verilog programming language, and the tools used in FPGA verification (test benches).Knowledge of system engineering and the ability to understand embedded software and programmable logic risk assessment from a system perspective.Membership in one or more professional societies and/or professional certification (e.g. CSQE, CSTE, etc.).Familiarity with FDA regulations and recommended practices, especially regarding software.Familiarity with ISO 13485, ISO 14971, IEC 62304 and other relevant industry standards EDUCATIONRequired BS degree (or higher) in Engineering, Computer Science, or related fieldEXPERIENCERequired A minimum of five (3) years in software testing and quality assurance.Preferred Five (5+) years experience in software testing and quality assurance of which minimum two (2) years experience should preferably be in the medical device field.ESSENTIAL DUTIES AND RESPONSIBILITIESThe Software V & V Engineer - II would be responsible forVerification and validation testing of embedded, real-time software, including the development of test plans and procedures. Participating in design reviews and code inspections and will support the development of documentation required for FDA device approval.Participation in other quality assurance functions, including, but not limited to, process audits, static code analysis, risk/hazard analysis, and test automation development. Defining of new product (Software), implementing operational profiles, preparing for test, executing test, and guiding the test.Implementation of a Software Reliability program.Support the qualification of third-party software components and tools used for software development and verification/valid
Degree: MCA/ PGDCA

Additional Degree: BE/ B.Tech (Engineering)

Experience: 5-10


Application Programming | Quality Assurance/Testing | Software Engineer
Applying for this job will take you to an external site


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