Automation Test Engineer at Niyam IT developing and executing testing frameworks for federal clients. Focused on compliance and quality in software delivery with Agile methodologies.
About the role
- Software Quality Test Engineer managing software verification and validation for a cardiac diagnostic device. Ensuring compliance with FDA standards in a collaborative, innovative environment.
Responsibilities
- Develop, write, and own clear and comprehensive software test plans, protocols, and procedures for a complex medical device system, ensuring full traceability to software requirements, at FDA’s “enhanced SW documentation level”.
- Drive the hands-on V&V effort by writing and integrating tests at multiple levels: unit tests directly into the C/C++ firmware and Python backend codebases, component tests for our React applications, and automated system-level tests.
- Design and execute comprehensive manual system-level and integration test protocols, particularly for scenarios involving real-world hardware interactions.
- Provide input into the requirements definition process to ensure all software requirements are clear, concise, and verifiable.
- Collaborate on a range of quality system documents, such as risk management files (e.g., swFMEA) and traceability matrices, to support the overall submission.
- Ensure all software testing activities and documentation comply with medical device standards (e.g., IEC 62304) and our internal Quality Management System (QMS).
- Proactively provide product quality feedback to Engineering and help drive root cause/fix to improve user satisfaction and user experience
- Voice of Quality for the Software team to influence software development to be compliant with applicable software development standards for medical devices.
- Own identification, qualification and maintenance of relevant software development and V&V tools per SandboxAQ’s Quality Management System (QMS)
Requirements
- B.S. in Computer Science, Electrical Engineering, or a related technical field.
- 7+ years of experience in a software quality or testing role, with a significant portion spent in the medical device industry.
- Strong programming proficiency, with demonstrated experience writing unit tests in both C/C++ and Python.
- Demonstrated, hands-on experience authoring and executing software V&V test plans and reports for a 510(k) medical device submission (both SiMD and SaMD).
- Deep understanding of medical device software development lifecycles and standards, particularly IEC 62304.
- Experience testing complex, multi-component systems that include firmware, software, and cloud elements.
- Authorization to work in the United States.
Benefits
- Competitive salaries
- Stock options depending on employment type
- Generous learning opportunities
- Medical/dental/vision
- Family planning/fertility
- PTO (summer and winter breaks)
- Financial wellness resources
- 401(k) plans
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