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Engineer II – SW V&V, Digital & Applications

Engineer II – SW V&V, Digital & Applications

ConfidentialBengaluru / Bangalore
30+ days ago
Job description
  • 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.
  • 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 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.
  • Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.
  • Support the SMEs on Regulatory responses and Audits, as needed.
  • 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 them. 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 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 field
    • 3 to 6 yrs of experience in Verification and validation testing of Software and hardware.
    • Relevant technical testing / reliability experience in software testing & automation.
    • Any scripting knowledge like python, shell etc. Good programming knowledge on selenium for automation testing.
    • Experience in desktop application, web application testing. Understanding of software architecture (web applications using Angular, microservice & cloud)
    • Test framework development and test harness development knowledge.
    • Knowledge on 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.

      • Skills Required

      Design Verification, Automation Testing

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