Senior Reliability Engineer at GE Healthcare

Waukesha, Wisconsin, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in engineering or STEM discipline
Certified Reliability Engineer (CRE-ASQ)
4+ years of reliability engineering experience in a highly regulated manufacturing/process-oriented industry
Proficiency in reliability analysis tools and software (e.g., Weibull++, ReliaSoft, etc.), and familiarity with medical device standards (e.g., ISO 13485, FDA regulations)
Proven ability to develop timely and effective technical solutions for challenging design/engineering problems
Subject matter expert in Reliability Engineering concepts and tools
Working knowledge of product development processes and product qualification steps
Prior Program or Project management experience (Agile methodology, etc.)
Ability to create long lasting relationships with stakeholders, building trust through effective communication and strong interpersonal connections
Strong influencing skills to manage change/conflicts/unforeseen events
Strong technical aptitude, including applicable engineering tools and systems
Desired Characteristics
Six Sigma black belt certification
Master’s degree in engineering or STEM discipline
Experience working in a highly regulated industry, preferably with time spent directly in product design, development, certification, testing, verification & validation activities
Knowledge of medical device regulations, test standards

Responsibilities

Collect and analyze reliability data (field performance data, service costs, complaints data, etc.) to identify quality/reliability trends and explore opportunities for improvement in current IB or in new product designs (NPIs)
Lead/participate to support product engineers on RCA (Root Cause Analysis) and FMEA activities to facilitate design analysis and brainstorming of key failure modes
Drive root cause analysis with an emphasis on identifying physics of failure
Develop and execute reliability testing protocols, including accelerated life testing, environmental testing, and stress testing to assure products meet project objectives on time
Create reliability test strategies and estimate resources to meet project or product goals
Guide engineers through creation and execution of reliability plans - especially around new product designs
Provide troubleshooting and CAPA expertise/assistance for unusual or persistent product problems thru the application of suitable L6S (Lean Six Sigma) tools & methodologies
Ensure reliability testing and documentation meet all relevant internal and external standards and is consistent with guidelines for medical devices to assure regulatory compliance (FDA, IEC 60601, etc.)
Effectively communicate to Quality, Supply chain, and Engineering teams regarding application and use of reliability processes, strategies, and tools
Coach and train the next generation of GEHC product engineers on DFR methodology - concepts, processes, standards, and tools
Provide Sub Matter Expertise (SME) in assessing and quantifying tech (reliability) risks in New Product Introduction (NPI) as well as existing IB
Focus on preventative measures while providing tech support (in areas like root cause analysis, test protocols, FMEAs, V&V, etc.) to product engineers to address recurring quality/reliability failures
Create and manage effective dashboards to show overall DFR status highlighting progress around reliability planning and execution on several key programs/project milestones including technical design reviews

Skills

Reliability Engineering

DFR

FMEA

Root Cause Analysis

RCA

Accelerated Life Testing

Environmental Testing

Stress Testing

V&V

CAPA

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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