Medical Device Test Engineer

2 weeks ago

Pittsburgh, Pennsylvania, United States Net2Source Inc. Full time

Job Summary:

We are seeking a highly skilled Medical Device Test Engineer to join our team at Net2Source Inc. As a Medical Device Test Engineer, you will be responsible for ensuring the quality and safety of medical devices and systems through rigorous testing and verification processes.

Key Responsibilities:

  • Requirement Analysis and Coordination:
    • 1. Gather and analyze requirements from product owners, QA leads, and programming leads.
    • 2. Communicate testing requirements to offshore teams.
    • 3. Coordinate testing deliverables between offshore teams and product owners, QA leads, and programming leads.
  • Managing End-to-End Product Verification and Validation:
    • 1. Provide estimates of tasks based on various techniques and historical data.
    • 2. Provide technical guidance to teams on testing requirements and optimal testing solutions.
    • 3. Create test plans, test strategies, test scenarios, test cases (protocols/procedures), and test data according to software testing requirements.
    • 4. Develop and test clinical scenarios based on medical domain knowledge.
    • 5. Maintain traceability matrices for test cases with requirements.
    • 6. Review test cases (protocols/procedures) created by offshore teams.
  • Testing of Medical Devices/Systems:
    • 1. Prepare systems for testing, including software installation and complete system calibration of all models.
    • 2. Execute system and software tests on Cori Arthroplasty Surgical System in compliance with Smith & Nephew's software development procedures.
    • 3. Conduct various levels of testing, including functional, integration, regression, and formal testing, generating test documentation and reports.
    • 4. Perform performance/reliability testing of Smith and Nephew devices.
    • 5. Conduct formal verification of protocols/procedures for Smith and Nephew devices using automation and manual techniques.
    • 6. Verify Smith and Nephew devices for FDA regulatory standards.
    • 7. Perform expert-level testing based on medical domain knowledge and new trends in the industry.
  • Issues/Defects Tracking and Test Reporting:
    • 1. Raise and track defects for software failures in Jira.
    • 2. Analyze the impact of defect fixes and new implementations.
    • 3. Generate test summary reports for management review and create periodic status reports on sprint and release testing efforts for metrics and defect triage generation.
  • Onshore-Offshore Coordination:
    • 1. Coordinate with offshore teams to regularly connect and identify challenges.
    • 2. Resolve bottlenecks and provide timely responses to enable teams to proceed.
    • 3. Coordinate with offshore teams on issues requiring hardware dependencies, Smith & Nephew approvals, and working with Smith & Nephew leads and managers on understanding and analyzing requirements and field defects.

Requirements:

  • Manual Test Development: Level of Proficiency 5
  • Automated Test Execution: Level of Proficiency 4
  • User Story, Requirement Analysis: Level of Proficiency 3
  • Defect Reporting, Re-Verification: Level of Proficiency 2
  • Onshore-Offshore Coordination: Level of Proficiency 1

About Us:

At Net2Source Inc., we believe in creating a culture that values diversity, inclusivity, and employee well-being. We strive to provide a supportive environment that fosters growth, innovation, and strategic impact. Our commitment to equal employment opportunity ensures that all candidates are considered based on their qualifications and abilities, without regard to age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.

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