Engineer II, Verification & Validation

Overview

As a System Verification Test Engineer for the Infusion Pumps team within the Medication Delivery business, you will support Design Verification activities for medical devices, including system-level, functional and performance testing.

What you'll do

• Lead, execute, summarize and report verification test activities for medical devices.
• Understand User Requirements and System Requirements, prepare system-level test cases and prepare test procedures.
• Understand product functionality and perform functional and performance testing.
• Lead and support Design Verification activities.
• Perform Installation, Operational and Performance Qualification protocols.
• Prepare traceability matrices and final reports.
• Support compliance and closure of regulatory and quality requirements.
• Follow test instructions and test protocols, including instructions from Design Engineers during test execution.
• Support Design Engineers in test fixture creation and in building up and tearing down test equipment.
• Support lab logistics and maintain material supplies for testing requirements.
• Support calibration activities.
• Diagnose, isolate and investigate problem reports and defects.
• Work with external test houses, such as EMI and EMC testing providers, to define test scope, author test plans and procedures, execute testing and consolidate reports.
• Follow good documentation and Good Manufacturing Practices in the Verification process.
• Interact with the Design team to resolve test-related technical issues.
• Present findings and objective evidence with rationale regarding 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, Industrial Engineering or a related field.
• Overall 5 to 8 years of experience, with a minimum of 2 years in System Verification testing and performance testing.
• Hands-on experience in overall final Design Verification/Validation testing of medical products.
• Relevant technical testing or reliability experience in electro-mechanical and electrical testing of medical devices.
• Understanding of test methods and processes used to verify products in mechanical, electrical and functional testing environments.
• Basic hands-on experience in data analysis of performance testing and sample size calculations for variable and attribute data.
• Experience with tools such as Minitab for data analysis, JIRA for defects and ALM for the test environment.
• Understanding of hardware and software product design methodologies and test practices.
• Experience in medical device or similar product development, Design Verification/Validation, system integration across hardware, subsystems and software, risk management, reliability engineering, process validation and quality systems.
• Basic understanding of and adherence to FDA, MDD/MDR, ISO and IEC design control procedures, regulations and standards.
• Self-motivation and good interpersonal skills.
• Ability to follow instructions clearly.

Nice to have

• Experience in Infusion Pumps Design Verification testing.

Details

• Location: Bangalore, Karnataka.