Engineer, II Verification & Validation

Overview

Independently verify and validate medical devices, from components through full system, with minimal supervision, while providing technical support on V&V activities. Reports to the V&V Manager for PSS/GSS unit of HST.

What you'll do

• Author, execute, perform, summarize and report out verification and validation test activities for components through full system devices, including Test Plans, Test Procedures, User and Functional Requirements testing, and Installation/Operational/Performance Qualification Protocols.
• Support compliance and closure of regulatory and quality requirements before completing design outputs and program deliverables.
• Support qualification of lab areas and productivity improvement efforts, including testing, building fixtures, calibration and data collection.
• Diagnose, isolate and investigate problem reports; drive product improvements and/or bug fixes.
• Work with external test houses (such as EMI and EMC tests for electrical boards and full devices) to define test scope, author test plans and procedures, and execute and consolidate reports.
• Ensure good documentation and Good Manufacturing Practices are followed in the Verification and Validation process.
• Participate in continuous improvement, V&V development process improvement and test automation.
• Maintain awareness of current regulatory trends and their impact on V&V status of equipment and processes.
• Support SMEs on regulatory responses and audits as needed.
• Adhere to the Baxter Quality Management System and support quality audits.
• Present findings and objective evidence with rationale, including applicability and exclusions.
• Identify and report quality or compliance concerns and take immediate corrective or preventive action as needed.

What you'll need

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical Engineering, 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 and the methods used to verify product in software, mechanical, electrical, functional and environmental testing environments.
• Experience 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 and hardware), risk management, reliability engineering, process validation and quality systems.
• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
• Demonstrated experience in accomplishing objectives.
• Ability to deliver on multiple projects simultaneously.
• Self-motivated with good interpersonal skills.

Nice to have

• Deep domain knowledge in design verification and validation of medical devices.

Details

• Location: Bangalore.
• Reporting to the V&V Manager for PSS/GSS unit of HST.