Lead System Engineer

Job Description Summary Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the user s needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation. Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results.
The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description

• Working with customers, marketing, clinical and field personnel to refine requirements, defining customer needs and required feature functionality early in the development cycle.
• Translating required functionality to system goals include quality, reliability, usability, serviceability, manufacturability, and cost.
• Working across functions and team boundaries to define, design, and implement the next generation of products with an inclusive system design process, especially engaging sub-system and functional teams.
• Be responsible for delivery of technical content and quality management deliverables.
• Work closely with technical teams to define design from high-level architecture, through technology selection and evaluation.
• Act as primary author and reviewer of system architecture, test design, design descriptions and customer documentation.
• Conducting trade off studies, and then proceeding with design synthesis.
• Driving implementation of the best design, and System Verification & Validation strategy
• Leading risk management, design defect management and system design review.
• Handling post-production activities include customer complaints analysis, periodic risk assessment and continuous improvement.
• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones.
• Complete all planned Quality & Compliance training within the defined deadlines.

• Bachelor s Engineering Degree in STEM Majors (Science, Technology, Engineering and Math)

• A minimum of 8+ years of technical & professional experience in Medical Device Industry in the capacity of systems engineer/development engineer/Verification.
• Demonstrated experience driving CTQ flow-down to subsystems.
• Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.
• Demonstrated broad exposure to systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, System, etc.).
• Demonstrated problem analysis and solving ability and results orientation.

• Demonstrated experience with ISO and regulatory compliance process, design history file and collaterals are in place and current.
• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
• Excellent verbal and written communication skills.
• Self-starter, energizing, results oriented, and able to multi-task.