Essential Responsibilities:
Diagnose and investigate field issues arising out of customer complaints. Solve product safety, quality & performance issues experienced in the clinical environment with thorough root cause analysis.
Track status and communicate progress effectively to the IB engineering leader by working with customers, supplier quality, manufacturing, field service, complaint handling team and engineers to understand the clinical and other circumstances that may have contributed to the issue.
Participate in reviewing closure criteria for complaints and continuously work to improve the process alongside complaint handling team.
Perform data analysis to characterize issues within our product portfolio and to direct design and process changes to improve our products. Familiarity with computer applications such as Microsoft Excel and Word, AI and online tools.
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables.
Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible.
Qualifications/Requirements:
BS in Engineering (any discipline) or equivalent experience (defined as a High School Diploma/GED and 4 years relevant work experience).
Ability to investigate, analyze and resolve issues on product or processes.
Proven ability to lead, influence, and partner effectively in a manner that supports a diverse global, collaborative, and cross-functional environment.
Proven analytical, interpersonal, communication, organization, planning and leadership skills.
Process focus and continuous improvement orientation.
Must be willing to work in our Salt Lake City, Utah facility full-time.
Desired Characteristics:
Two years’ experience in medical device industry or equivalent safety critical industry.
Understanding of IEC60601-1 and particular standards for patient parameters.
Familiarity with ISO 13485 or 21 CFR related regulations.
Self-starter, energizing, results oriented, and able to multi-task.
Excellent teamwork, coordination and communication skills.
Effective oral and written communication skills.
Global project experience
Circuit design and simulation tool experience
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal 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