GE HealthCare Lead System Designer Invasive Cardiology 

United States, Wisconsin 

791255307

As a Lead System Designer (LSD), you will lead engineering activities focused on maintaining product continuity and improving variable cost productivity (VCP) for the Invasive Cardiology product line. You will define product requirements, ensure product traceability, manage risks, and oversee verification and validation processes, all while ensuring compliance with the GE Healthcare Quality Management System. In this role, you will collaborate with other program leaders to define scope and drive on-time, high-quality project delivery.

Roles and Responsibilities

• Scope and plan engineering deliverables for VCP and installed base Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
• Ensure the product development process adheres to the GE Healthcare Quality Management System, Phase Review Discipline, and market-specific regulatory requirements.
• Analyze design changes and related risk management activities to develop verification and validation test plans and reports.
• Apply technical expertise and data analysis to support recommendations and decision-making.
• Use judgment to solve moderately complex tasks or problems.
• Lead engineering activities for small projects with moderate risks and resource requirements.
• Develop and update clear and testable user and product-level requirements.
• Drive planning and execution of engineering-specific activities in collaboration with other program leaders.
• Manage defect resolution activities for design changes, including analysis and SPR disposition.
• Provide internal and external audit support for engineering design changes.

Required Qualifications

• Bachelor’s degree in STEM with a minimum of 3 to 5 years progressive engineering experience.
• Demonstrated experience with requirements management, quality management systems, and regulatory compliance processes.
• Proven engineering experience to drive technical decision-making for lower-risk programs/projects.
• Experience working with cross-functional stakeholders and leading engineering activities.
• Experience in a matrix organization with strong influencing and negotiation skills.

Desired Characteristics

• Strong oral and written communication skills.
• Strong interpersonal and leadership skills.
• High attention to detail.
• Experience with global regulations (ISO 13485, FDA, MDR, etc.).
• Demonstrated ability to analyze and resolve problems.