Lead Product Engineer (Daily M-F 8:00 AM – 5:00 PM)

GE HealthCare•State College, PA

23h•Onsite

About The Position

The Lead Install Base Product Engineer for Ultrasound Transducers is responsible for the technical performance and lifecycle management of assigned components, product areas, and install base activities within GE HealthCare’s ultrasound probe portfolio. The role is an experienced technical contributor and leader who applies engineering judgment and systems-level thinking to address issues in assigned areas, collaborating across design engineering, manufacturing, quality, service, and sourcing to support customer satisfaction, product reliability, and manufacturability. The engineer leads cross-functional efforts to troubleshoot field issues and resolve design-related manufacturability challenges; executes engineering changes (ECR/ECO); and leads or supports quality events such as non-conformances, investigations, CAPAs, and supplier changes. The position supports product performance and continuity of the installed base throughout its lifecycle, including technical documentation, quality and compliance activities, supplier support, and cross-functional problem solving.

Requirements

Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
At least 4 years of experience in product engineering, manufacturing engineering, sustaining engineering, or a related technical discipline.
Demonstrated experience troubleshooting product issues.
Demonstrated experience with root cause analysis and structured problem solving.
Demonstrated experience with engineering change management (ECR/ECO processes).
Experience supporting quality investigations, including CAPA, non-conformances, and complaints.
Experience in cross-functional engineering environments.
Strong systems-level thinking and analytical skills.
Excellent communication and collaboration skills across functions and cultures.

Nice To Haves

Experience in design, manufacturing, or sustaining engineering of medical devices.
Familiarity with ultrasound transducers or similar electromechanical systems.
Knowledge of high-density interconnects, flex circuits, or cable assemblies.
Knowledge of design controls and post-market surveillance.
Experience working with suppliers and global manufacturing environments.
Experience with supplier change requests and component qualification.
Familiarity with FDA regulations (21 CFR Part 820) and ISO 13485 quality systems.
Background in reliability engineering or field performance analysis.
Lean Six Sigma experience.
Red X problem-solving experience.

Responsibilities

Maintain the technical performance and integrity of the Design History File (DHF) for assigned ultrasound transducer products, ensuring evidence, traceability, and documentation remain complete and credible throughout the product lifecycle.
Serve as an engineering point of contact for assigned install base health, reliability, and design-driven manufacturability activities.
Prioritize issues based on customer impact, risk, and business needs.
Define, scope, and execute assigned Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) through implementation and closure.
Evaluate design, process, and supplier changes for impacts on patient safety, product requirements, quality, reliability, manufacturability, serviceability, cost, and the installed base.
Drive cross-functional alignment and approvals for changes and ensure robust documentation, qualification, and implementation.
Lead and support non-conformances (NCs), investigations (INVs), and corrective and preventive actions (CAPAs).
Perform root cause analysis and ensure effective corrective and preventive actions are implemented.
Partner with Quality and Regulatory teams and support audits, inspections, and post-market surveillance activities.
Support supplier investigations and technical issue resolution; evaluate, qualify, and approve Supplier Change Requests (SCRs).
Collaborate with Supplier Quality and Sourcing on supplier performance improvement.
Provide technical input for component selection, obsolescence management, and redesign.
Lead assigned cross-functional problem-solving efforts across engineering, quality, manufacturing, supply chain, and service.
Influence technical and business decisions without direct authority and represent install base needs in design and strategic discussions.