- 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. Valuable 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

📌 Sr Eng, Software V&V (Bengaluru)
🏢 Baxter India
📍 Bengaluru