Evaluate system integration points and lead planning and testing efforts across wearable devices, mobile applications, cloud software, and user portals.
Develop and execute comprehensive verification and validation test plans to ensure system performance, safety, and security.
Create detailed system models, perform risk analyses, and develop mitigation strategies for complex medical device ecosystems.
Collaborate with development engineers to analyze system performance, reliability, and data integrity from data collection to cloud processing.
Serve as a subject matter expert in applying systems engineering standards and best practices throughout the product lifecycle.
What's Needed?
Bachelor’s or Master’s degree in Electrical, Biomedical, Computer, or Systems Engineering, or related fields.
5+ years of experience in systems engineering, particularly with connected medical devices or complex hardware-software systems.
Intermediate knowledge of hardware qualification, statistics, and familiarity with CAD is a plus.
Experience with automation, scripting (Python, RESTful API), and CI/CD tools like Azure DevOps is advantageous.
Strong debugging skills, understanding of design and requirement management tools, and experience with medical device regulations