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GE HealthCare Sr Staff Systems Engineer Onsite 
United States, Wisconsin 
529700396

15.08.2024

providing a quality product that meets the user’s needs.This role will be onsite 2-3 days a week.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. Impacts the team's ability to achieve service, quality and timeliness of objectives. The role is subject to operating policy objectives. There is moderate autonomy within the role. High levels of operational judgment are required to achieve outcomes required.


Roles and Responsibilities

  • Own Patient Care Solutions product systems feature and clinical application development projects including technical risk retirement, safety and regulatory compliance.
  • Collaborates with different disciplines and cross functions including engineering platform teams, user experience, quality, regulatory, marketing, manufacturing, product management, research teams, and customers.
  • Primary responsibility for all systems engineering tasks for product throughout the medical device development phases associated with multi-generational new product introductions.
  • Leading and providing overall guidance for a team of systems engineers, defining/providing input to program priorities, and assessing schedule risk - benefit analysis.
  • 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.
  • Lead product development activities across functions and team boundaries to define, design, and implement new products and product improvements.
  • Responsible for delivery of technical content and quality management deliverables.
  • Work closely with technical teams to define design from high-level architecture, through technology selection and evaluation.
  • Mentor 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.
  • 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.

Required Qualifications

  • Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math).
  • Minimum of 7 years of engineering experience in a related field.
  • Good knowledge of requirements generation, reliability planning & demonstration, failure mode analysis, SDLC and standards.
  • Understanding of software system design concepts and subsystem interactions and interfaces.
  • Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems.
  • Minimum of 2 years experience leading a team of engineers in product development. .

Desired Characteristics

  • Experienced in GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
  • Expertise in/understands Medical Device Software Design Principals, requirements for meeting various country regulatory clearances, and demonstrates awareness of industry dynamics.
  • Demonstrated experience with quality and regulatory compliance processes.
  • Proven track record of successful problem definition, technical decomposition, and project estimation.
  • 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.
  • Knowledge of software design principals, cybersecurity principals, cloud development, microservice architecture, distributed systems, multi-tenancy, orchestration, scalability, Web technologies enabled application development, and edge computing.
  • Experience in one more computer languages including 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.