Job Title: Lead System Designer (LSD) Functional Role
Waukesha WI or Milwaukee WI
Role Overview:
The Lead System Designer (LSD) plays a key functional role in the product development lifecycle. This position is responsible for reviewing all product designs, developing primary design documentation, performing system-level debugging, and ensuring compliance with GE Healthcare s Quality Management System (QMS).
The LSD acts as the technical authority for system-level design integrity, ensuring all components and subsystems integrate effectively to meet performance, reliability, and safety requirements.
Key Responsibilities:
Product Review & Design Ownership:
Lead and review system-level architecture and design documentation for new and existing products.
Develop and maintain Primary Design Documents (PDDs) that define the overall system configuration and performance expectations.
FMEA and Risk Management:
Prepare and review FMEA (Failure Modes and Effects Analysis) documents to identify and mitigate potential design risks early in the product lifecycle.
System-Level Debugging & Validation:
Conduct system-level analysis and debugging of complex issues across hardware, software, and integration interfaces.
Collaborate with cross-functional teams to ensure proper system validation and verification.
Quality & Compliance:
Ensure all design activities are in line with GE Healthcare s QMS standards and regulatory compliance requirements.
Drive adherence to design controls, documentation standards, and audit readiness.
Cross-functional Collaboration:
Work closely with engineering, manufacturing, quality, and regulatory teams to deliver robust, compliant designs.
Provide technical leadership and mentorship to design and development teams.
Qualifications & Requirements:
Experience: Prior GE Healthcare experience is mandatory, specifically within QMS processes or as a Lead System Designer (LSD).
Technical Skills: Strong understanding of system engineering principles, product lifecycle management, and risk management documentation (FMEA, DFR, etc.).
Tools & Standards: Familiarity with GE Healthcare design and documentation tools, regulatory standards (e.g., IEC 60601, ISO 13485), and quality processes.
Soft Skills: Excellent analytical, documentation, and communication skills with the ability to work cross-functionally.
Summary:
This role is ideal for a system engineering professional with prior GE Healthcare experience who can lead system-level design activities, ensure QMS compliance, and contribute to the development of safe and reliable healthcare products.
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