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GE HealthCare · 1 day ago

Lead Engineer

State College, PA

Full-time

Onsite

Senior Level

5+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. They are seeking a Lead Install Base Engineer to provide engineering support for probe products, ensuring performance and compliance while collaborating with cross-functional teams to resolve issues and enhance customer satisfaction.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

Responsibilities

Serve as the technical expert for installed base probe products, providing engineering support for field issues, service needs, and product performance

Partner with Quality, Regulatory, Service, and Engineering teams to investigate and resolve product issues

Lead root cause analysis (RCA) efforts to identify systemic issues and implement corrective and preventive actions (CAPA) that improve product reliability and customer experience

Support the complaint and Customer Satisfaction Opportunity (CSO) processes to ensure timely and effective resolution of customer concerns

Lead risk management activities related to installed base products, including risk assessments conducted as part of the Engineering Change Order (ECO) process

Maintain and review Risk Assessment and Controls (RACs) and Cause Mitigation Tables (CMTs) per the Risk Management Procedure

Provide risk management guidance during New Product Introduction (NPI) activities

Maintain and update Design History File (DHF) documentation for installed based probe products to ensure alignment with regulatory and quality system requirements

Ensure traceability of design changes, risk mitigation activities, and post-market surveillance data within the DHF to support audits and regulatory submissions

Support Engineering Change Orders (ECOs) and documentation updates related to product improvements, obsolescence, or compliance-driven modifications

Qualification

Risk management principlesProduct development experienceRegulatory standards knowledgeRoot cause analysisDHF documentation maintenanceCAPA processes knowledgeMicrosoft Office SuiteAnalytical skillsCommunication skillsOrganizational skillsCollaborative work

Required

Bachelor's degree in Engineering, Biomedical Engineering, or a related field

Minimum 5 years of experience in product development within a regulated industry

Ability to travel annually up to 10% (Domestic/International)

Demonstrated understanding of risk management principles and practices

Strong organizational, analytical, and time management skills

Excellent verbal and written communication

Proficiency in Microsoft Office Suite

Proven ability to work collaboratively in a global, matrixed environment

Ability to work in the office daily

Preferred

In-depth knowledge of global regulatory standards (e.g., FDA, EU MDR, ISO 13485, ISO 14971)

Experience conducting and documenting product risk assessments

Familiarity with root cause analysis techniques

Experience maintaining DHF documentation and supporting regulatory audits

Working knowledge of document control systems and engineering change management tools

Experience supporting post-market surveillance and complaint investigations

Knowledge of CAPA processes and quality improvement methodologies

Benefits

Professional development

Challenging careers

Competitive compensation

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees