Senior Software Engineer - V&V Careernet

6.0 - 10.0 years

30 - 32 Lacs

Bengaluru

Work from Office

Key Skills: Verification Validation, Squish, Medical Device, Selenium, Python Roles and Responsibilities: Author, execute, perform, summarize, and report verification and validation test activities of components to a full system device. Develop and maintain: Test Plans Test Procedures User and Functional Requirements Testing Design Verification IQ/OQ/PQ Protocols Traceability Matrices Final Reports Support compliance and closure of regulatory and quality requirements before completing design outputs/program deliverables. Apply understanding of Risk Management, FMEA, critical/essential parts identification, system reliability, life/limits testing, and related V&V tasks. Participate in the development of V&V methodologies per Quality/Regulatory requirements and industry best practices. Lead qualification of lab area, productivity improvement, testing, fixtures, calibration, and data collection. Diagnose, isolate, and investigate problem reports; drive product improvements and bug fixes. Collaborate with external test houses (e.g., EMI/EMC) to define scope, author test plans, execute, and consolidate reports. Ensure Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) in V&V process. Participate in continuous improvement by supporting implementation of process and product quality initiatives. Possess deep knowledge in test automation tools and developing automation suites. Experience with IEC basic safety, EMI-EMC standards. Work closely with auditees to understand details and provide objective evidence. Adhere to Baxter Quality Management System and support quality audits. Support ongoing regulatory inspection readiness via self-assessments, mock inspections, and updated compliance. Engage with design & development teams early in the cycle for testability, traceability, and test coverage. Conduct pre-verifications/dry runs to refine test plans and procedures. Resolve test-related technical issues with design team. Present findings/objective evidence with rationale and clear applicability or exclusions. Identify/report any quality or compliance concerns and take corrective/preventive action. Skills Required: 5 to 10 years of experience in V&V testing of software, hardware, and systems. Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing. Understanding of test methods and verification processes in software, mechanical, electrical, functional, and environmental contexts. Experience in writing system, subsystem, and module-level V&V plans, procedures, test execution, and reporting. Familiarity with product design methodologies and test practices for both hardware and software. Understanding of reliability theory and analysis related to test quantities. Experience in medical device or similar domain involving system integration (software & hardware), risk management, and regulatory compliance. Deep domain knowledge in medical device design V&V is a plus. Adherence to FDA, ISO, IEC design control procedures, regulations, and standards. Demonstrated ability to deliver on multiple simultaneous projects. Self-motivated with strong interpersonal skills. Education: Bachelor's Degree in related field

Posted 2 days ago

Apply

Software Engineer Careernet

5.0 - 10.0 years

15 - 17 Lacs

Bengaluru

Hybrid

Key Skills: System Design, Verification Validation, Test Management, Test Cases, System Testing Roles and Responsibilities: Understand URS (User Requirements) / System Requirements and prepare the System Level Test Cases and Test Procedures. Understand the product functionality and perform Functional and Performance Testing for the product. Lead/Support and perform all Design Verification activities. Perform Installation, Operational, and Performance Qualification Protocols. Prepare Traceability Matrices and Final Reports. Support compliance/closure of Regulatory and Quality Requirements. Follow Test Instructions and Test Protocols. Follow instructions clearly from Design Engineers during Test Execution. Support Design Engineers in Test Fixture Creation, Building Up & Tearing Down Test Equipment. Support Lab Logistics and maintain the material supply for Testing Requirements. Support Calibration Activities. Skills Required: Diagnose, Isolate, and Investigate Problem Reports and Defects. Support work with external test houses (e.g., EMI, EMC tests for electrical boards and full devices) to define the Test Scope, Author Test Plans and Procedures, Execute Tests, and Consolidate Reports. Ensure Good Documentation and Good Manufacturing Practices are followed in the Verification Process. Experience in IEC Basic Safety and EMI-EMC Standards. Interact with the Design Team to resolve Test-Related Technical Issues. Present findings/objective evidence with rationale, including applicability/exclusions. Identify and report any Quality or Compliance concerns and take immediate Corrective/Preventive action as needed. Education: Bachelor's Degree in related field

Posted 4 weeks ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.