Senior Product Engineer
State College, PA - USA
Job Summary
The engineer will lead cross-functional efforts to troubleshoot field issues and address design-related manufacturability challenges execute engineering changes (ECR/ECO) and drive resolution of quality events including non-conformances CAPAs and supplier changes. This role requires a broad engineering background strong systems-level thinking and the ability to effectively collaborate with global teams to sustain product performance and ensure continuity of the installed base throughout its lifecycle.
At our State College site teams design manufacture and service diagnostic medical ultrasound transducers (probes) used across a wide range of clinical applications including surgery urology cardiology and radiology. As a high-mix low-volume regulated manufacturing environment the site combines advanced engineering precision manufacturing and lifecycle support to deliver critical imaging technology that enables clinicians to make real-time decisions in patient care.
Product & Install Base Ownership
Own the technical performance and integrity of the Design History File (DHF) for assigned ultrasound transducer products ensuring alignment and sustainment throughout the product lifecycle
Serve as the primary engineering point of contact for install base health reliability and design-driven manufacturability
Drive prioritization of issues based on customer impact risk and business needs
Engineering Change Management (ECR/ECO)
Define scope and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)
Evaluate design process and supplier changes for impact on patient safety quality cost and the installed base
Drive cross-functional alignment and approvals for changes
Ensure robust documentation qualification and implementation of changes
Quality & Compliance Support
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
Support audits inspections and post-market surveillance activities
Supplier & Procurement Support
Support supplier-related 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 guidance for component selection obsolescence management and redesign
Cross-Functional Leadership
Lead cross-functional problem-solving efforts across engineering quality manufacturing supply chain and service
Influence decision-making without direct authority
Act as the voice of the install base in design and strategic discussions
Bachelors degree in Electrical Engineering Mechanical Engineering Biomedical Engineering or a related field
6 years of experience in product engineering manufacturing engineering or sustaining engineering
Experience troubleshooting product issues and driving root cause analysis
Experience with structured problem solving and engineering change management (ECR/ECO)
Experience supporting quality investigations (CAPA NCs complaints)
Proven ability to operate in cross-functional engineering environments
Strong systems-level thinking and analytical capability
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
Understanding of design controls and post-market surveillance
Experience working with suppliers in global manufacturing environments
Experience with supplier change requests and component qualification
Familiarity with FDA (21 CFR Part 820) and ISO 13485
Background in Reliability engineering or field performance analysis
Lean Six Sigma
Red X problem solving
Excellent communication and collaboration skills across functions and cultures
#LI-VS1
We will not sponsor individuals for employment visas now or in the future for this job opening.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: Yes
Required Experience:
Senior IC
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients