Software Quality Assurance Engineer
3 days ago
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.
- 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.
- 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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