Title : Medical Device Software Unit Test Engineer
Location : Wayne, New Jersey (Hybrid working on confirming onsite requirements)
Type : W2 contract
Job description :
Our client is a global medical technology company that provides products and solutions for healthcare and life sciences.
We are seeking a highly skilled Unit Test Engineer to join our team for a temporary engagement in the development and testing of Class III medical devices.
The ideal candidate will be proficient in C++ and have experience with advanced unit testing tools such as VectorCAST and Rhapsody Model Driven Development.
This role will involve collaborating with cross-functional teams to ensure the quality, reliability, and compliance of software systems integral to medical devices.
The Unit Test Engineer will report to the Senior Software Engineer Manager of R&D.
Responsibilities :
Develop, execute, and maintain unit tests for software components used in Class III medical devices.
Use VectorCAST Unit Test Tool to create and automate unit test cases to validate the functionality of embedded software.
Work with the Rhapsody Model Driven Development Tool to generate and test code from UML-based models.
Ensure that all unit testing complies with industry standards, regulatory requirements, and company quality protocols.
Identify, document, and troubleshoot issues found during unit testing and collaborate with the software development team to implement solutions.
Review and analyze UML diagrams and system models to ensure comprehensive test coverage.
Ensure that software verification aligns with both FDA and ISO standards for medical device software development.
Collaborate with cross-functional teams including software engineers, systems engineers, and regulatory specialists.
Required Skillset :
Proficient in C++ programming languages.
Hands-on experience with VectorCAST for automated unit testing.
Strong knowledge and experience using IBM Rhapsody for model-driven development.
Understanding of Unified Modeling Language (UML) to interpret system models and software designs.
Familiarity with Class III medical device software development standards and regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Strong problem-solving skills and attention to detail.
Preferred Qualifications :
Prior experience working in the medical device industry, particularly with Class III devices.
Knowledge of embedded systems and real-time operating systems (RTOS).
Experience with regulatory submissions and audits for medical device software.
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