remote
Senior Software Quality Engineer - TIDI Products, LLC
Software Engineer
Lead software quality for medical device systems, driving validation, test automation, and regulatory compliance using Python, C++, and advanced test frameworks to ensure SaMD/SiMD standards are met.
About the role
Key Responsibilities
- Lead end‑to‑end software quality and validation activities for medical device systems, ensuring compliance with Design Controls and SaMD/SiMD regulatory requirements.
- Design, develop, and maintain automated test frameworks in Python and C++ to accelerate regression and integration testing.
- Collaborate with software, systems engineering, manufacturing, and external partners to define quality metrics, test plans, and risk mitigation strategies.
- Drive continuous improvement of the Quality Management System, including process documentation, audit readiness, and corrective action management.
- Provide technical guidance and mentorship to junior QA engineers and cross‑functional teams.
Requirements
- 5+ years of experience in software quality engineering for medical devices or regulated industries.
- Proficiency in Python and C++ for test automation and scripting.
- Deep understanding of SaMD/SiMD regulatory frameworks and Design Controls.
- Experience with test automation frameworks (e.g., pytest, CppUnit) and CI/CD pipelines.
- Strong analytical, problem‑solving, and communication skills.