Verified today
Senior Engineer, System Verification
About the role
Senior Engineer, System Verification at Baxter India leads system verification and validation of infusion pumps, prepares test cases, performs functional and performance testing, drives design verification, conducts qualification protocols, ensures regulatory compliance, supports design engineers, plans lab logistics, diagnoses defects, coordinates external EMI/EMC testing, documents verification per GMP.
What you’ll do
- Lead and execute system verification test activities for medical devices
- Prepare system level test cases and procedures
- Perform functional and performance testing
- Lead design verification activities
- Conduct installation, operational, performance qualification protocols
- Prepare traceability matrices and final reports
- Ensure regulatory and quality compliance
- Develop test instructions and protocols
- Support design engineers with test fixture creation and equipment setup
- Plan lab logistics and maintain material supply
- Diagnose and investigate defects
- Coordinate external test houses for EMI/EMC testing
- Document verification process following GMP
What you’ll bring
- Bachelor in Mechanical, Electrical, Software, Computer Science, Bio-Medical, Industrial Engineering or related field
- 6-10 yrs experience, 3+ yrs System Verification testing
- Hands‑on final design verification/validation of medical products
- Experience in electro‑mechanical, electrical testing of medical devices
- Proficiency in data analysis of performance testing and sample size calculations
- Skilled with Minitab, JIRA, ALM
- Knowledge of FDA, MDD/MDR, ISO, IEC design control procedures
Nice to have
System V&V Engineers with Experience in Infusion pumps design verification testing
Skills
Education
Bachelor