Eng II, V&V

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your Role at Baxter

The role of V&V Engineer is to make technical contributions 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 Software Manager PSS.

What you’ll be doing

• Review, Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device: Which includes but is 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 all relevant objective evidence
• 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 test-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
• 5 to 8 years 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 of hardware in loop and software in loop testing.
• An understanding of test methods and processes as well as the methods used to verify products 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

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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