Job Description Summary

Job Description

Role 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

• Bachelors 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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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.