System Engineer

The Systems Engineer will lead systems engineering activities for medical device product development, including requirements development, standards decomposition, risk management, FMEA, V&V planning, and traceability across the V-model. The role requires strong experience in electromechanical medical devices with hardware, software, and regulatory compliance responsibilities., * Develop product-level and element-level requirements with clear rationales.

• Interpret and decompose medical device standards including IEC 60601-1-11, ISO 80601-2-70, and ISO 80601-2-72.
• Lead deep-dive FMEA activities and translate risk findings into subsystem requirements.
• Ensure control measures are documented in the Risk Management File and Design History File.
• Define system-level risks and drive requirements into software, electrical, and mechanical subsystems.
• Develop V&V protocols, test plans, and traceability matrices across the V-model.
• Review system documentation and design artifacts for compliance and completeness.
• Lead technical reviews and align cross-functional teams including R&D, manufacturing, regulatory, and quality.
• Support process improvements within the systems engineering framework.

• Systems Engineering, Systems Architecture, and Systems Design
• Medical device standards: ISO 14971 and IEC 60601 series
• New Product Development and full product lifecycle experience
• Electromechanical device development with hardware and software elements
• Requirements analysis and requirements traceability
• Risk Management and FMEA
• Verification & Validation planning
• Regulatory and quality compliance
• Product Development Lifecycle Management
• Cross-functional technical leadership
• Simulation tools, CI/CD, and continuous improvement methodologies
• Experience in system architecture, system design, hardware engineering, or related areas.
• Certified Systems Engineering Professional certification.

Constellation Energy + Cheswick, PA + $118,800-132,000 per year Who We Are As the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have be…, Constellation Energy + Gibsonia, PA + $118,800-132,000 per year Who We Are As the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have be…, At BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financi…