Lead Engineer

Job Description SummaryGE HealthCare is seeking a Lead Install Base Engineer to join our Ultrasound team on-site in State College, PA. In this role, you will provide engineering support for probe products across the installed base, ensuring ongoing performance, reliability, and compliance. You will collaborate with cross functional teams to resolve post-market issues, lead risk management activities, drive quality improvements, and enhance overall customer satisfaction. Occasional travel to customer sites may be required to support issue resolution and strengthen relationships.
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Job DescriptionRole 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

Required Qualifications

• 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 Qualifications

• 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

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We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Additional Information

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.