Engineer, II Verification & Validation

Baxter International Inc.; Bengaluru; On-site; INR 700,000 - 1,300,000; Full time

Job summary

Baxter International Inc. in Bengaluru, India, is seeking a Verification & Validation Engineer II to independently verify and validate medical device software, hardware and systems with minimal supervision.

The role encompasses defining, initiating and documenting testing activities, and training others as needed. You will author test plans, execute validation activities, support regulatory compliance, and collaborate with cross-functional teams to ensure product quality and patient safety.

Qualifications

• Bachelor's degree in a relevant engineering field.
• 3–7 years of experience in verification and validation testing of software, hardware and systems.
• Experience with electro-mechanical, electrical, or software testing environments.

Responsibilities

• Author, execute and summarize verification and validation tests for components and full systems.
• Prepare test plans, procedures and qualification protocols.
• Support regulatory and quality requirements prior to design outputs and program deliverables.
• Collaborate with external test houses for EMI/EMC testing and report consolidation.
• Maintain Good Manufacturing Practices documentation and participate in quality improvement initiatives.

Skills

Verification & Validation

Software testing

Hardware testing

System testing

Regulatory awareness

Test automation

Education

Bachelor's degree in Engineering

Job description

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 Verification & Validation Engineer II is to independently Verify and Validating the device with minimal / no supervision. In addition to providing technical support and service in these areas, the incumbent may also perform the following functions: requisitioning, defining, initiating, specifying, documenting and training.

This position is based out of Bangalore and reporting to the V&V Manager for PSS/GSS unit of HST.

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,
• Installation/Operational/Performance Qualification Protocols,
• Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
• Support 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 (Electromagnetic Interference), EMC (Electromagnetic Compatibility) 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
• Participate in Verification and Validation 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
• Adheres to Baxter Quality Management system & supports the quality audits.
• 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
• 3 to 7 years of experience in Verification and validation testing of Software, hardware and System.
• Relevant technical testing/reliability experience in electro-mechanical, electrical, or software 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, system 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.