Lead Engineer at GE Healthcare

State College, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical TechnologyIndustries

Requirements

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

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 base 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

Skills

Key technologies and capabilities for this role

Root Cause AnalysisCAPARisk ManagementRACsCMTsEngineering Change OrderDesign History FileNPIUltrasound ProbesMedical Devices

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This is an on-site position in State College, PA.

What are the required qualifications for this Lead Engineer role?

Candidates need a Bachelor’s degree in Engineering, Biomedical Engineering, or a related field, minimum 5 years of experience in product development within a regulated industry, and up to 10% annual travel.

What skills are essential for success in this role?

Key skills include demonstrated understanding of risk management principles, strong organizational, analytical, and time management skills, excellent verbal and written communication, proficiency in Microsoft Office Suite, and ability to work collaboratively in a global, matrixed environment.

What is the company culture like at GE HealthCare?

GE HealthCare fosters an inclusive environment where every voice makes a difference, emphasizing collaboration with cross-functional teams and a purpose to create a world where healthcare has no limits.

What makes a strong candidate for this Lead Engineer position?

A strong candidate will have the required bachelor's degree and 5+ years in regulated product development, plus preferred in-depth knowledge of global regulations, strong risk management expertise, and proven collaboration skills in matrixed teams.

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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