Sr Systems Analysis Engineer, Medical Devices
$100,000–$130,000 year
On-site · Bloomington, Indiana, United States
Job Summary
Senior Systems Analysis Engineer for medical devices responsible for ensuring overall functionality, safety, and efficacy of medical devices; leads design, development, and integration of firmware, software, hardware, electronics, and disposables. Develop system architectures and specifications, define user requirements and software requirements, conduct risk analysis for system/software/cybersecurity, lead systems integration across engineering disciplines, ensure compliance with ISO/IEC standards (ISO 13485, IEC 60601, IEC 62304, ISO 14971), collaborate effectively with cross-functional teams, and continuously improve processes and methodologies in line with Design Controls and SDLC. Requires BS degree (MS preferred), 5+ years in system requirements/design/testing, experience with multi-tasking RTOS, Agile development, and familiarity with tools like GitHub and Azure DevOps; travel up to 25%.
Required Qualifications
- BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
- Minimum of 5 years of experience analyzing system requirements, design, and testing
- Software integration, and black box testing methodologies
- Experience with multi-tasking real-time operating system
- Agile development experience
- Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971
- Experience and understanding of Design Controls and SDLC
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