Baxter
Bengaluru, Karnataka, India Posted 5d ago
Join Baxter as a Verification & Validation Engineer II to independently verify and validate medical devices with minimal supervision. You will contribute to our mission of saving and sustaining lives through rigorous testing and quality compliance.
Key Responsibilities
Author, execute, summarize, and report out verification & validation test activities for components to full system devices.
Support compliance and closure of Regulatory and Quality requirements before completing design outputs.
Support lab area qualification, productivity improvement, fixture building, calibration, and data collection.
Diagnose, isolate, and investigate problem reports to drive product improvements and bug fixes.
Work with external test houses for EMI and EMC testing to define test scope and execute reports.
Ensure good documentation and Good Manufacturing practices are followed in the V&V process.
Participate in continuous improvement activities and test automation.
Maintain awareness of current regulatory trends and support SMEs on regulatory responses and audits.
Requirements
Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering, or a related field.
3 to 7 years of experience in verification and validation testing of software, hardware, and systems.
Relevant technical testing or reliability experience in electro-mechanical, electrical, or software testing.
Understanding of test methods and processes for software, mechanical, electrical, functional, and environmental testing.
Experience in writing system, subsystem-level, and module-level V&V plans, procedures, test execution, and reports.
Understanding of hardware and software product design methodologies and test practices.
Familiarity with reliability theory and analysis.
Experience in medical device or similar product development, design V&V, system integration, risk management, reliability engineering, process validation, and quality systems.
Understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
Preferred Qualifications
Deep domain knowledge in design verification and validation of medical devices.
