What you'll be doing

- 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
- 3to 6yrs 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.
- 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
- Valuable Team player.

📌 Engineer II, Software V&V - PSS (Bengaluru)
🏢 Baxter India
📍 Bengaluru