Job Description
Job Title: System Test Engineer
Job Location: Pittsburgh, PA
Job Duration: 3 Months, Contract to Hire
Job Summary:
- As a System Test Engineer, the candidate will be responsible for verification of web applications in cloud environment and verification of robotic surgical platform devices.
- The candidate 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.
- The candidate will collaborate across engineering disciplines to develop and execute robust test strategies.
Job 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.
Mandatory Skills:
- 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
Optional Skills:
- Experience in Test Automation using scripting language like Python.
Job Tags
Contract work,