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Job Responsibility:
Own and maintain interoperability verification requirements, including traceability from system and interface requirements to verification evidence
Develop and execute verification plans, test cases, and test procedures for interoperability-related requirements
Perform system-level and interface-level verification testing for device-to-device and device-to-IT connectivity
Support system integration testing activities for connected medical device solutions
Collaborate with Systems and Software Engineering teams to ensure interoperability designs are verifiable and testable
Assess interoperability-related changes and determine verification impact and required test coverage
Troubleshoot and support resolution of interoperability defects identified during verification and integration testing
Generate clear, compliant verification documentation and evidence to support design control and regulatory needs
Apply understanding of clinical workflows and intended use when defining representative verification scenarios
Demonstrate working knowledge of FDA, ISO, IEC, and software lifecycle standards as they apply to verification of connected medical devices
Contribute to continuous improvement of interoperability verification methods, tools, and best practices
Requirements:
Bachelor's degree in Engineering (Systems, Biomedical, Computer, Electrical, or related discipline)
2+ years of experience in medical device or regulated product development, with a focus on verification activities
Systems engineering background with strong experience in requirements management, traceability, and verification planning
Hands-on experience with system, interface, or integration verification testing
Familiarity with medical device interoperability concepts, healthcare IT integration, or connected systems
Experience participating in design control and change management processes
Strong technical documentation, organization, and analytical skills
Effective written and verbal communication skills for cross-functional collaboration
Experience with requirements and verification tools (e.g., DOORS, ALM tools) preferred
Exposure to healthcare data exchange mechanisms or interface specifications is a plus
Nice to have:
Experience with requirements and verification tools (e.g., DOORS, ALM tools)
Exposure to healthcare data exchange mechanisms or interface specifications