Lead Systems Engineer - Product Development

MS0059 GE Medical Systems Information Technologies, Inc.; Waukesha (WI); On-site; USD 120,000 - 170,000; Full time

Job summary

GE HealthCare in Wisconsin seeks a Lead Systems Designer to drive Software-Oriented Architecture components and a common network framework for patient monitoring devices. You will own systems engineering across medical device development, including requirements, architecture, verification, and regulatory compliance.

You will lead engineers, collaborate with cross-functional teams, and ensure scalable, cost-effective solutions while aligning with global regulations and manufacturing/support needs.

Qualifications

• Bachelor’s Degree in Computer Science or STEM fields.
• Minimum of 6 years engineering experience or GE HealthCare Edison Engineering Program with 4 years.
• Minimum of 3 years of experience with product development and design control processes.
• Minimum of 1 year of experience in one or more languages such as C/C++/C#/Java/Python.
• Understanding of software system design concepts and subsystem interactions.
• Willing to come on site a minimum of 3 days a week in Waukesha, WI.
• Legal authorization to work in the U.S.; no visa sponsorship.

Responsibilities

• Own Patient Care Solutions product system feature and clinical application development projects including risk retirement, safety and regulatory compliance.
• Lead design teams with design control processes including requirements flow down, system design, risk analysis, integration and test, verification and validation, manufacturing, field and customer support.
• Collaborate with engineering platforms, UX, quality, regulatory, marketing, manufacturing, product management and customers to define architecture and technology choices.
• Manage multi-generational new product introductions and guide a team of systems engineers on priorities and schedule risk.
• Ensure compliance activities and deliverables across the subsystem and coordinate with stakeholders worldwide.

Skills

Engineering experience

Design control

Programming in C/C++/C#/Java/Python

Software system design

Regulatory compliance knowledge

On-site in Waukesha, WI

Education

Bachelor's degree in CS or STEM

Master's degree in CS or related STEM

Tools

Docker/Kubernetes

REST Web Services

Cloud deployment (SaaS/PaaS/IaaS)

Job description

Job Description Summary

Come and join the Monitoring Solutions team as we develop technology that profoundly impacts critical care for the betterment of clinicians and patients. We are looking for a Lead Systems Designer to focus on the development of Software-Oriented Architecture (SOA) components along with a common network framework (SDK) that will be utilized across our patient monitoring devices. This new framework is critical to the Patient Care Solutions innovation roadmap and will expand across many of our new and existing products within the Patient Care Solutions business and the GE HealthCare portfolio. The Lead Systems Designer has the primary responsibility for all systems engineering tasks for a product throughout the medical device development phases. Maintains ownership of customer workflow, feature functionality, product quality, reliability, serviceability, manufacturability, regulatory, compliance, and cost. Activities include requirements development and flow down, architecture / system design and analysis, components integration, modeling, FMEA, developing/executing system verification and validation test procedures, reliability testing, providing support to manufacturing teams, and resolving customer issues.

Here’s a link to learn about our products and what we’re building: https://www.gehealthcare.com/products/patient-monitoring/portrait-mobile

Job Description Roles and Responsibilities

Own Patient Care Solutions product system feature and clinical application development projects including technical risk retirement, safety and regulatory compliance. Lead product development activities across functions and team boundaries to define, design, and implement new products and product improvements. Lead design teams with design control process including requirements flow down, system design, design analysis, risk analysis, integration and test, verification and validation, manufacturing, field and customer support including Corrective and Preventative Actions to ensure customer satisfaction. Work closely with technical teams to define design from high-level architecture, through technology selection and evaluation. Collaborates with different disciplines and cross functions including engineering platform teams, user experience, quality, regulatory, marketing, manufacturing, product management, research teams, and customers. Own all systems engineering tasks for your product throughout the medical device development phases associated with multi-generational new product introductions. Lead and provide overall guidance for a team of systems engineers, defining/providing input to program priorities, and assessing schedule risk – benefit analysis. Serve as the primary product representative for internal and external compliance activities. Develop and implement software/hardware development strategies. Corrective and Preventative Actions, and compliance implementation plans across a subsystem consisting of 100+ engineering resources. Responsible for delivery of technical content and quality management deliverables. Ensure that the solutions are timely in nature, perform detailed comparative analysis of solutions options with global stake holders, and ensure solutions are scalable, sustainable, fault tolerant, and within operational cost budgets. Work closely with technical teams to manage technical program risks, design tradeoffs, track technical program outcomes through established metrics. Proactively address potential defect areas in complex systems and ensure compatibility between subsystems and dependent systems.

Required Qualifications

• Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math).
• Minimum of 6 years of engineering work experience in a related field or a graduate of the GE HealthCare Edison Engineering Program with 4 years of work experience.
• Minimum of 3 years of experience with product development and design control processes.
• Minimum of 1 years of experience in one or more computer languages such as: C/C++/C#, Java, Python, or similar language.
• Understanding of software system design concepts and subsystem interactions and interfaces.
• Willing to come on site a minimum of 3 days a week and work directly with our development team located in Waukesha, Wisconsin.
• Willingness to work flexible hours to collaborate with global team members.
• Legal authorization to work in the U.S. is required.
• We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

• Team leadership experience and demonstrated facilitation and negotiation skills.
• Development/Review of design requirements at domain level, aligning architectural requirements with software development strategy and regulatory requirements.
• Proven track record of successful problem definition, technical decomposition, and project estimation.
• Knowledge of software design principles, cybersecurity principles, cloud development, microservice architecture, distributed systems, multi-tenancy, orchestration, scalability, Web technologies enabled application development, and edge computing.
• Experience with AI used in process development and product development lifecycle.
• Knowledge of technologies including Docker/Kubernetes, REST Web Services, architecture across SaaS/PaaS/IaaS, and cloud deployment.
• 3+ years of work experience as a Systems Engineer in a software or product development team.
• Masters degree in Computer Science or a related STEM Major.
• Experienced in GE HealthCare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position.
• Expertise in/understands Medical Device Software Design Principles, requirements for meeting various country regulatory clearances, and demonstrates awareness of industry dynamics.
• Demonstrated experience with quality and regulatory compliance processes.

Additional Information

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

#LI-MA4

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

Additional Information 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: No At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.