Lead Systems Engineer

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.
• Collaborate 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.
• Ensure that the solutions are timely in nature, perform detailed comparative analysis of solutions options with global stakeholders, 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.

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 one more computer languages such as C/C++/C#, Java, Python, or similar language.
• 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.
• Demonstrated experience with quality and regulatory compliance processes.