Description

You will execute system verification and validation for complex robotic systems, ensuring alignment with product requirements and regulatory standards.

Responsibilities

• Author and manage verification plans, protocols, test cases, traceability matrices, and summary reports.
• Ensure traceability between requirements, test protocols, and results to support FDA, EU MDR, and ISO 13485 submissions.
• Identify, report, and track hardware/software defects using JIRA; validate fixes and support root cause analysis.
• Coordinate with lab management to ensure adequate equipment, personnel, and space availability.
• Contribute to Agile transformation efforts, including test-driven development, BDD, and AI-assisted test automation.

Required Skills

• 5+ years of experience in systems verification, validation, or quality engineering.
• Strong understanding of Medical Device regulations including FDA, EU MDR, and ISO 13485.
• Proficiency with JIRA for defect tracking and backlog management.
• Experience with Agile methodologies, including test-driven development (TDD) and behavior-driven development (BDD).
• Ability to trace requirements through test protocols to final results.
• BS or MS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering.

Key Skills

Education

Bachelor's degree