Fmea Engineer Jobs in Milwaukee, WI (NOW HIRING)

Job Description SummaryThe Senior Systems Engineer for Cardiology Systems is a cross-functional engineering leader, responsible for all systems engineering activities throughout the Cardiology Systems product development lifecycle. The role ensures alignment of customer workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost objectives.
Key responsibilities include requirements definition and flow-down, system architecture and design, integration, modelling, risk management (FMEA), verification and validation testing, reliability assessment, manufacturing support, and resolution of customer issues. The role applies systems engineering principles to translate requirements into effective product solutions through design trade-off analyses, integration, and verification.
This position influences engineering approaches, projects, and programs within the business, driving improvements in product quality, team effectiveness, and operational efficiency. This role requires strong technical expertise, sound judgment, the ability to coach and influence cross-functional team members, as well as significant input into priorities, processes, and strategic decisions.Job Description

Roles and Responsibilities

• Lead end-to-end systems engineering activities for cardiology products throughout the medical device development lifecycle, from concept through commercialization and post-market support.
• Own the definition, development, and delivery of product features and clinical applications, including requirements management, architecture development, design analysis, integration, verification, validation, and risk management.
• Drive technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements.
• Lead cross-functional development teams across engineering, clinical, quality, regulatory, product management, manufacturing, service, and marketing organizations.
• Ensure effective requirements flow-down and traceability from customer and clinical needs to subsystem and component-level specifications.
• Conduct system design trade-off analyses and make data-driven decisions that balance performance, reliability, manufacturability, serviceability, scalability, and cost objectives.
• Lead design control activities including FMEA, hazard analysis, verification and validation planning, reliability testing, defect prevention, and corrective and preventive actions (CAPA).
• Serve as the primary systems engineering representative for internal and external audits, regulatory submissions, product reviews, and compliance activities.
• Provide technical leadership and mentoring to systems engineering teams, influencing program priorities, development strategies, and execution plans across multiple product generations.
• Collaborate closely with global stakeholders to resolve complex technical challenges, manage dependencies across subsystems, and ensure seamless product integration and customer satisfaction.
• Support manufacturing, field service, and customer issue resolution activities, driving root cause analysis and continuous product improvement initiatives.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related STEM discipline.
• Minimum of 8 years of engineering work experience in product development
• Minimum of 6 years of experience with systems engineering, product development, and design control processes within the medical device, healthcare technology industry, or other highly regulated industry.
• Demonstrated understanding of product development lifecycle, requirements management, risk management, verification and validation, and regulatory compliance.
• Experience leading cross-functional product development teams and complex technical programs.
• Knowledge of system architecture, subsystem integration, and software-hardware interactions.
• Strong analytical, problem-solving, communication, and stakeholder management 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

• Masters degree in in Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related STEM discipline.
• 9+ years of engineering work experience in product development
• Demonstrated experience in systems engineering methodologies in cardiology or healthcare product development, and clinical workflow development.
• Expertise in FMEA, reliability engineering, and healthcare quality management systems.
• Demonstrated experience leading new product introductions and multi-generational product development programs.
• Working knowledge of FDA, MDR, IEC 60601, IEC 62304, ISO 14971, and related medical device standards.
• Proven ability to lead and influence technical strategy, mentor engineering teams, and drive execution across global organizations.
• Tech-Savvy & Future-Focused: demonstrated ability to stay ahead of the curve with a strong interest in emerging technologies and digital innovation
• Growth-Oriented Attitude: Bring a problem solving and motivating mindset along with being adaptable, intellectually curious, and eager to learn and take on new challenges to meet business goals

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.