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Sr Eng, Software V&V

Sr Eng, Software V&V

ConfidentialBengaluru / Bangalore
30+ days ago
Job description
  • Review, Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device : Which includes but not limited to :
  • Test Plans, Test Procedures, User and Functional Requirements testing,
  • Design Verification,
  • Installation / Operational / Performance Qualification Protocols,
  • Traceability Matrices and
  • Final Reports.
  • Support compliance / closure of Regulatory and Quality requirements before completing Design Outputs / Program Deliverables.
  • Clear understanding of the elements of Risk Management, FMEA, critical / Essential parts identification, System reliability, Life / limits testing and related V&V tasks.
  • Participate in the development of Verification & 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 and Good Manufacturing practices are followed in the Verification and Validation Process
  • Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives
  • Deep knowledge in test automation tools and realizing test automation suite.
  • Work closely with the auditees to understand the details and support with all relevant objective evidences
  • Adheres to Baxter Quality Management system & supports the quality audits.
  • Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations.
  • Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Identify issues early to fix the same. Refine the test plans and procedures through pre-verifications / Dry runs.
  • Interacts with design team to resolve tests-related technical issues.
  • Presents the findings / objective evidences 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 Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
    • 6 to 10 yrs 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.
    • An understanding of test methods and processes as well as the methods used to verify product in the realms of; software, mechanical, electrical, functional and environmental testing environments.
    • Experience in - writing system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation
    • Understanding of hardware and software product design methodologies and test practices.
    • Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability.
    • Experience in medical device or similar product development, design verification / validation, software integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems
    • 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

      • Skills Required

      Automation Testing, Design Verification

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    Sr Eng Software • Bengaluru / Bangalore