Lead Engineer
Lead Engineer
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1 Vacancy
Job Description
Job Description Summary
GE HealthCare is seeking a Lead Install Base Engineer to join our Ultrasound team on-site in State College 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.GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.
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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We will not sponsor individuals for employment visas now or in the future for this job opening.Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual 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: No
Employment Type
Full-Time
