Software Quality Assurance Engineer

3 days ago


Reston, Virginia, United States Master Compliance Full time
Job Title: Unit Test Engineer

We are seeking an experienced professional to join our team at Master Compliance as a Unit Test Engineer. This role is focused on the development and testing of Class III medical devices, requiring expertise in C++ and advanced unit testing tools such as VectorCAST and IBM Rhapsody Model Driven Development.

Key Responsibilities:
  • Develop, execute, and maintain unit tests for embedded software in Class III medical devices.
  • Utilize VectorCAST for automating unit test cases to validate software functionality.
  • Collaborate using IBM Rhapsody to generate and test code from UML-based models.
  • Ensure that unit testing complies with FDA, ISO standards, and company quality protocols.
  • Identify and resolve issues discovered during unit testing, coordinating solutions with the software development team.
  • Analyze UML diagrams and system models to ensure thorough test coverage.
  • Ensure software verification aligns with FDA 21 CFR Part 820 and ISO 13485 standards.
  • Collaborate with software engineers, systems engineers, and regulatory specialists.
Required Qualifications:
  • Proficiency in C++ programming.
  • Hands-on experience with VectorCAST for automated unit testing.
  • Strong expertise in IBM Rhapsody for model-driven development.
  • Knowledge of Unified Modeling Language (UML) for interpreting system models and designs.
  • Familiarity with Class III medical device software standards and regulations, including FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
  • Strong problem-solving skills and keen attention to detail.
Preferred Qualifications:
  • Prior experience in the medical device industry, especially with Class III devices.
  • Knowledge of embedded systems and real-time operating systems (RTOS).
  • Experience with regulatory submissions and audits for medical device software.

The Unit Test Engineer will report to the Senior Software Engineer Manager of R&D and collaborate with teams to ensure compliance with industry and regulatory standards.



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