Lead System Designer – AI COE

GE HEALTHCARE•Remote, OH

8d•$100,000 - $150,000•Onsite

About The Position

The GE HealthCare AIS business includes an AI-enabled portfolio of MR, CT, Molecular Imaging, Women’s Health, X-ray, Ultrasound, Image-guided solutions, and enterprise imaging. These solutions enable more seamless workflows, faster and more precise decision-making, and real-time procedural support. As customers’ needs digital solutions continue to grow, the market for digital ultrasound solutions advances. The AI COE has a mission to develop a seamlessly connected world of devices and software that creates additional value for customers and patients, beyond devices alone. We aim to grow our offerings via organic as well as inorganic developments. We are looking for an experienced LSD to join our team. The primary responsibility of this role is to serve on the program team to deliver successful and timely NPI and ATD programs. In this role, you will work on AI product development, together with a cross-functional team within AI COE and across GEHC AIS segments.

Requirements

Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math)
A minimum of 5 years of professional experience in software or medical product development, program management, and/or related field, leading cross functional programs, life-cycle management, and/or large global projects
2-4 years’ experience in system engineering within engineering environment.
Demonstrated experience driving requirements development and management and flow-down to subsystems while ensuring traceability between design and test procedures.
Experience with AI development
Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization; able to build good working relationships

Nice To Haves

Master’s Degree in Computer Engineering/Computer Science or equivalent degree with 8 to 10 years’ experience in industry
Demonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentation
Strong knowledge of GEHC Phase Review Discipline (PRD) and regulatory process for medical device development
Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program
Demonstrated ability to balance multiple program priorities while meeting critical commitments
Demonstrated ability to work in a global matrixed organization and deliver results in an ambiguous environment
Self-starter - requires minimal direction to accomplish goals, proactive and enthusiastic
Strong team player – collaborates well with others to solve problems and actively incorporates input from various sources
Strong presentation skills - effectively able to present status, risks, and plans to senior leaders

Responsibilities

Be part of the core program team leading product development for innovative Ultrasound products
Have responsibility to ensure that product deliverables achieve all design objectives required to meet customer and business needs, including but not limited to feature and functionality, quality, reliability, serviceability, regulatory, compliance, and cost.
Be responsible for driving the end-to-end product development process from requirements capture to V&V and commercial release.
Leading the core team and design control process from requirements development, design planning to design transfer
Leading the core team in the development of verification and validation planning and execution for NPIs and released products
Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, field and customer support including corrective and preventative actions to ensure customer satisfaction
Ensure that the quality targets are satisfied and technical risks are addressed as they arise on the program or released product
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
Responsible for the validation of all GxP relevant applications and maintaining the validated state of those applications
Aware of and comply with the change management work instruction
Develop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectives