GE HealthCare Lead System Designer AI 

Remote, Remote 

607797574

Essential Responsibilities:

• Ensure that product programs achieve all design objectives required to meet customer and business needs, including: feature and functionality, quality, reliability, serviceability, manufacture-ability, regulatory, compliance, and cost.
• Drive the end-to-end product development process from requirements capture to V&V and commercial release.
• Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones;
• Lead the design team and design control process from requirements development, design planning to design transfer
• Lead the design team in the development of verification and validation planning and execution for NPIs and released products
• Develop requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, 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

Quality Specific Goals:

• 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
• 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

Basic Qualifications:

• Bachelor’s or Master Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math);
• Considerable 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; experience with AI development would be an advantage;
• Demonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentation;
• Relevant experience in project leadership within engineering environment;
• Demonstrated experience driving requirements development and management and flow-down to subsystems while ensuring traceability between design and test procedures;
• Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization; able to build good working relationships
• 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
• Willing to travel

Desired Characteristics:

• Master’s Degree in Computer Engineering/Computer Science or equivalent degree with 8 to 10 years’ experience in industry
• 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

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support