Expedite Technology Solutions LLC
US_East | Product / System & PLM Engineer_L2
Expedite Technology Solutions LLC, Bloomfield, New Jersey, us, 07003
Overview
Role: System Test Engineer Work location: Pittsburgh, PA Background and Meet and Greet: MANDATORY Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential Rationale: Verification of web applications in cloud environments and robotic surgical platform devices; end-to-end system testing; collaboration across engineering disciplines to develop and execute robust test strategies. Responsibilities
Execute System Verification & Validation: participate in developing and executing comprehensive test strategies for complex robotic systems, ensuring alignment with product requirements and regulatory standards. Author and manage verification plans, protocols, test cases, traceability matrices, and summary reports. Maintain 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) 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 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 and proficiency
3+ years of experience in medical device verification & validation testing Tools Experience: Jira, Cockpit, Windchill, or other requirements/test/work management tools Outstanding communication, facilitation, and coaching skills Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks Understanding of ISO 13485, IEC62304 and FDA QS Regulation 21 CFR Part 820 Experience with hardware, firmware, and software product development 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 Submission details (details that must accompany submission)
First Name, Middle name, and Last Name City and State Open to Relocate? Rate Availability Phone # Mobile # Email address Visa type Visa Expiration Date Hiring Status Contact: Mariana Zarate - ERM North America Tel.: +***
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Role: System Test Engineer Work location: Pittsburgh, PA Background and Meet and Greet: MANDATORY Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential Rationale: Verification of web applications in cloud environments and robotic surgical platform devices; end-to-end system testing; collaboration across engineering disciplines to develop and execute robust test strategies. Responsibilities
Execute System Verification & Validation: participate in developing and executing comprehensive test strategies for complex robotic systems, ensuring alignment with product requirements and regulatory standards. Author and manage verification plans, protocols, test cases, traceability matrices, and summary reports. Maintain 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) 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 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 and proficiency
3+ years of experience in medical device verification & validation testing Tools Experience: Jira, Cockpit, Windchill, or other requirements/test/work management tools Outstanding communication, facilitation, and coaching skills Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks Understanding of ISO 13485, IEC62304 and FDA QS Regulation 21 CFR Part 820 Experience with hardware, firmware, and software product development 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 Submission details (details that must accompany submission)
First Name, Middle name, and Last Name City and State Open to Relocate? Rate Availability Phone # Mobile # Email address Visa type Visa Expiration Date Hiring Status Contact: Mariana Zarate - ERM North America Tel.: +***
#J-18808-Ljbffr