Demo

System Test Engineer

TALENT Software Services
Pittsburgh, PA Full Time
POSTED ON 10/22/2025
AVAILABLE BEFORE 11/20/2025
Role: System Test Engineer

Work location: Pittsburgh, PA

Background and Meet and Greet: MANDATORY

Job Description:

As a System Test Engineer, he/she will be responsible for verification of web applications in cloud environment and verification of robotic surgical platform devices. He/She will be responsible for end-to-end system testing, verifying the system and sub-system requirements and creating DHF deliverables like Test Procedures and Test Reports. He/She will collaborate across engineering disciplines to develop and execute robust test strategies.

Key Responsabilities:

"""

  • Execute System Verification & Validation: participate in developing and executing comprehensive test strategies for complex robotic systems, ensuring alignment with product requirements and regulatory standards.
  • Participate in authoring and managing verification plans, protocols, test cases, traceability matrices, and summary reports.
  • Traceability: Ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
  • Equipment Planning: Coordinate with lab management to ensure adequate resources (equipment, personnel, lab space) are available to meet verification timelines.
  • Defect Management: Identify, report, and track hardware/software defects using tools like JIRA; validate fixes and support root cause analysis.
  • Agile & Automation Practices: Contribute to Agile transformation efforts, including test-driven development, BDD, AI-assisted test automation, and backlog management.
  • Cross-Functional Collaboration: Work closely with systems engineers, software and hardware teams, and global stakeholders to ensure seamless integration and testing.
  • Regulatory Compliance: Ensure traceability between requirements, test protocols, and results to support FDA, EU MDR, and ISO 13485 submissions.
  • Project Support: Provide input to technical project plans, risk registers, and design control documentation. Participate in design reviews and FMEAs.
  • Performance Tracking: Define and monitor KPIs such as test coverage, defect density, on-time sprint delivery, and verification cycle time to drive continuous improvement."""

What are the Mandatory skills and skill proficiencies required for this position?

"""

  • 3 years of experience in medical device verification & validation testing
  • Tools Experience: Jira, Cockpit, Windchill, or other requirements management, test management, and work management tools.
  • Outstanding communication, facilitation, and coaching skills
  • Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks and methodologies
  • Understanding of the application of ISO 13485, IEC62304 and FDA QS Regulation 21 CFR Part 820
  • Experience with product development involving hardware, firmware, and software elements
  • Experience presenting to executive level management on project status

Education:

  • BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering
  • MS or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, Biomedical Engineering

Salary : $40 - $42

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