Principal Software Validation Engineer

7 days ago

Bengaluru, Karnataka, India beBeeVerification Full time ₹ 1,04,000 - ₹ 1,30,878
Software V&V Engineer

What you'll be doing

  • Author, execute, perform, summarize, report out verification and validation test activities of components to a full system device. This includes creating and executing test plans, test procedures, user and functional requirements testing, design verification, installation/operational/performance qualification protocols, traceability matrices, and final reports.
  • Ensure compliance and closure of regulatory and quality requirements before completing design outputs/program deliverables.
  • Participate in the development of verification and validation methodologies in accordance with applicable quality/regulatory requirements and industry best practices.
  • Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration, and data collection.
  • Diagnose, isolate, and investigate problem reports. Drive product improvements and/or bug fixes.
  • Ensure good documentation practices are followed in the SW Verification and Validation Process.
  • Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.
  • Participate in V&V development process improvement and test automation.
  • Maintain awareness of current regulatory trends and their impact on the verification and validation status of equipment and processes.
  • Support SMEs on Regulatory responses and Audits as needed.
  • Pair up with design and development teams to start testing early in the design cycle to ensure requirements testability, design traceability, and test coverage. Identify issues early to fix them. Refine test plans and procedures through pre-verifications/dry runs.
  • Interact with design teams to resolve tests-related technical issues.
  • Present findings/objective evidence and able to present with rationale with applicability/exclusions.
  • Identify and report any quality or compliance concerns and take immediate corrective/preventive action as needed.

What you'll bring

  • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering, or related fields.
  • 3-6 years of experience in Verification and Validation testing of software and hardware.
  • Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing.
  • Understanding of hardware schematic diagrams and debugging tools like IC5000, CAN Analyzer, Trace 32, Keil IDE, PEAK analyzer, Oscilloscope.
  • Any scripting knowledge like Python, shell, etc. Good programming knowledge and basic understanding of Embedded programming.
  • Understanding of modeling (MATLAB, Simulink, etc.).
  • Test framework development and test harness development knowledge.
  • Knowledge on hardware-in-loop and software-in-loop testing.
  • Relevant technical testing/reliability experience in software testing and test methods and processes.
  • Experience in writing System, Subsystem-level, and Module-level software verification and validation plans, procedures, Test Execution, and Test report generation.
  • Understanding of software product design methodologies and test practices.
  • Experience in medical devices or similar products in software integration.
  • Deep domain knowledge in design verification and validation of medical devices is a plus.
  • Understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
  • Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.
  • Self-motivated with good interpersonal skills.
  • Good team player.

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