Wauwatosa, Wisconsin, USA
3 days ago
Lead System Designer (Invasive Cardiology)
Job Description SummaryAs 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.

The Invasive Cardiology business delivers solutions for Hemodynamic and Electrophysiology recording systems, including departmental and enterprise-wide solutions, allowing customers to access patient data easily and securely within their respective domains.

Job Description

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.

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: Yes

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