Senior Systems Engineer

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.

Desired Characteristics

• Masters degree 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.