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Senior Engineer, V&V, Respiratory Health

5.00 to 10.00 Years   Bangalore   06 Feb, 2023
Baxter India
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    The role of Senior V&V Engineer is to make technical contribution in understanding system requirements and developing/updating the test protocols & procedures for the new and / or existing products at Sub system and System level. It includes verification and validation, environmental, performance, reliability and safety/regulatory related tests and executing the same, documenting the reports.This position is based out of Bangalore and reporting to the V&V Manager for Respiratory Health division of Front Line Care.Essential Duties and Responsibilities :
    • 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.
    • Works with external test houses(such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports
    • 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.
    • Experience in IEC basic safety, EMI-EMC standards
    • 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.
    ,

Keyskills :
safetycommissioningsiteinspectiontroubleshootingtest automation toolsverification

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