Medical Device Test Engineer

Company DescriptionSARACA is a global engineering and R&D services company serving industries such as MedTech, Aerospace, Automotive, and more, with over 25 Fortune 500 customers. As an ISO 13485-certified organization, SARACA specializes in innovative medical device design and development across all device classes, including embedded software, UI/UX, mechanical systems, and product testing. The company holds expertise in regulatory standards like IEC 62304 and EU MDR, as well as crafting clinical and performance evaluation reports. With a team of 400+ skilled engineers and consultants, SARACA provides exceptional solutions for diverse global projects. As an equal-opportunity employer, SARACA fosters a culture of innovation and continuous learning, with a vision to empower clients in achieving industry leadership. We are currently hiring for an Embedded Software Test Engineer role with a leading Medical Devices organization in Burlington, MA (Onsite). This is an excellent opportunity to work on safety-critical embedded systems and contribute to high-quality healthcare solutions.Key Responsibilities: • Create and maintain test documentation in compliance with FDA, IEC 62304, ISO 13485, and related standards • Participate in risk management activities to identify software-related hazards and mitigations • Define test coverage based on software requirements and risk analysis • Design and execute functional, integration, regression, and system-level test cases • Ensure traceability between requirements and test cases • Develop automated test scripts for embedded systems • Design test environments and fixtures to simulate real-world conditionsRequired Skills: • Bachelor’s degree in computer science, Electrical Engineering, Biomedical Engineering, or related field • 6+ years of experience in embedded software testing (preferably in medical devices) • Strong understanding of SDLC and V-model • Knowledge of regulatory standards (FDA, IEC 62304, ISO 13485) • Experience with embedded debugging tools and techniques