Product Engineer

**No Sponsorship of any kind: H1B Spousal or OPT **
** $5k sign on to be used for relocation **
** Onsite in Salt Lake City 5 days a week **

At our Salt Lake City site engineering research and manufacturing teams come together to design and build surgical imaging technologies including advanced C-arm imaging systems that support image-guided procedures for clinicians across the globe. The work here contributes to the precision and capability clinicians bring into the OR every day.

The Product Engineer role entails evaluating and investigating product issues that come through customer complaints or non-conformances. Trend and handle incoming complaints and non-conformances to improve product quality and meet regulatory requirements.

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 experience in medical device industry).

• 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 engineering 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

We will not sponsor individuals for employment visas now or in the future for this job opening.

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.