Computer System Validation Manager Jobs in Wisconsin

Job Description SummaryJoin a dynamic team working with Agile (SAFe) to develop next generation Cardiology digital applications. The Systems Engineer is responsible for leading and executing systems-level design activities for digital product development in cloud, mobile and artificial intelligence for Cardiology. This role works as a key contributor within cross functional teams to translate user needs into well defined system requirements, drive robust design execution, and support verification and validation efforts in compliance with internal processes and regulatory standards.
This role focuses on hands on technical leadership, collaboration, and disciplined application of systems engineering practices to deliver high quality, manufacturable, and serviceable products. Join this high-powered team leading advanced technology solutions at GE HealthCare!Job DescriptionRoles and Responsibilities

• Provide Systems Design leadership for new product development programs in Cardiology as a key contributor on a crossfunctional team.
• Lead and support the engineering team in the execution of the design process, including requirements management, risk management (including FMEA), design principles including manufacturability, serviceability, reliability, testability, verification, validation, compliance with internal processes and applicable industry standards, and design transfer to production.
• Participate in defining product architecture, test strategies, and design requirements, balancing performance, complexity, risk, manufacturability, serviceability, and quality.
• Develop, maintain, and manage user and system requirements in alignment with product and program objectives.
• Drive design evolution across multi-generation product releases with an emphasis on platforming, re-use, and reliability.
• Contribute to the development and execution of verification and validation strategies for new product introduction (NPI) and changes to released products.
• Support manufacturing and the installed base team through investigation and implementation of corrective and preventive actions to maintain customer satisfaction.
• Develop and maintain clear requirements traceability to ensure alignment from user needs through verification and validation.
• Manage requirement updates and changes throughout the product lifecycle, assessing impacts and coordinating with crossfunctional teams.
• Ensure quality objectives are met and support the identification and mitigation of technical risks throughout development and postrelease.
• Support regulatory and quality activities, including audits (FDA and Internal) and preparation and maintenance of Design History Files (DHFs).

Required Qualifications

• Bachelor's Degree in Computer Science or STEM-related field
• Minimum of 6 years of experience in project leadership or systems engineering within a manufacturing, development, or research environment
• Minimum of 3 years or experience with product development and design control processes
• Demonstrated experience in product development, including requirements definition through verification and validation.
• Demonstrated ability to facilitate technical trade-offs and decision making
• Working knowledge of risk management methodologies, including FMEA.
• Strong written and verbal communication skills.
• Willingness to work a hybrid schedule with three days per week on-site at the GE HealthCare office located in Waukesha, Wisconsin
• Demonstrated flexibility in approach to work hours, and willingness to partner with and accommodate global teams and schedules
• 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

• Master's Degree in Computer Science or STEM-related field
• 7+ years of medical device or regulated product development experience.
• Experience using requirements management tools to create, maintain, and trace product requirements in a collaborative development environment (e.g., DOORS, Jama, ALM).
• Experience in one or more computer languages including C/C++/C#, Java, Python, or similar language
• Familiarity with medical device standards such as IEC 606011, ISO 14971, IEC 62304, and related regulatory and safety standards.
• Organized, proactive, and resultsoriented; able to manage multiple priorities with support.
• Ability to make informed technology choices when exploring technology options and analyzing the impact of technology decisions
• Ability to convey technical information to cross functional program team members.
• Exposure to systems engineering frameworks and methodologies, with certifications such as INCOSE ASEP, CSEP, or ESEP

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

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.