Senior Systems Engineer

Role: Senior Systems Engineer for Cardiology Systems, leading all systems engineering activities across the product development lifecycle to ensure customer workflow alignment, quality, reliability, regulatory compliance, and manufacturability. Responsibilities: define requirements, develop system architecture, perform integration, modeling, risk management (FMEA), verification, validation, and support manufacturing. Lead cross-functional teams spanning engineering, clinical, quality, regulatory, and manufacturing; serve as primary technical representative in audits and compliance; mentor teams and influence program strategies. Requirements: Bachelor's in Engineering or related STEM field; 8+ years in product development and 6+ years in systems engineering within regulated industries like medical devices; strong expertise in requirements management, risk analysis, design control, and regulatory standards (e.g., IEC 60601, ISO 14971). Preferred: Master's degree, 9+ years experience, healthcare product development, knowledge of clinical workflows, and experience with FDA, MDR, and other standards. HighValue: cardiology, healthcare technology, medical device development lifecycle, design control, risk management, regulatory compliance, and cross-functional leadership. WorkSetup: hybrid schedule based in Waukesha, Wisconsin, with global stakeholder collaboration.