Embedded tester - Unique System Skills LLC

Experience in Manual testing – Medical devices

• Test Planning, Test case design, Test cases writing, Test case review and test results reviews, Defect Logging, Defect Analysis. Regression testing
• Hands on experience in SDLC/STLC process.
• Compliance Analysis, Compliance Plan document, User Requirements document, Functional Requirements document, Risk Assessment document
• System Test Protocol/ Scripts, User Acceptance Test Protocols/ Scripts, System Test Reports, User Acceptance Test Reports, Compliance Report
• Hands on experience in preparing test cases using Black box testing techniques
• Able to create Test Cases from the Functional Specifications / Software Requirement Specification document.
• Able to test the Functionality as per the Test plan and respective Test Cases.
• Good communication skills /  He has to work  independently with customer
• Hands on experience in leading, mentoring, assigning the work to team members and has worked in effort estimation.
• Exposure to ISO13485, 14971
• Knowledge on FDA regulations and guidelines.
  • Team Interaction with Cross function stakeholders
  • Technical reviews of Verification work products
  • Coordination between team members
  • Obtain clarifications and feedback from Customer
  • Organize reviews and team meetings.
  • Release deliverables and project administrative activities