Systems Engineer

Key Responsibilities

• Contribute to the specification, design, component selection, system integration, verification, and validation of medical imaging systems and electromechanical subsystems.
• Develop an in-depth understanding of system architecture design and clinical use of medical imaging systems.
• Propose system definitions and specifications to meet customer requirements and user needs.
• Support concept development, specification, and design of new medical imaging products.
• Implement new electromechanical designs and modifications within defined cost, schedule, and performance targets.
• Maintain traceability between system requirements and subsystem requirements.
• Maintain traceability between product requirements, identified risks, and mitigation strategies.
• Perform hands-on troubleshooting at system and subsystem levels.
• Support engineering teams and system quality assurance through concept, implementation, and verification phases.
• Collaborate with design engineers to define test methods and conditions.
• Create project schedules, track progress, and report status or issues to management and project teams.
• Support design transfer to manufacturing.
• Establish collaborative relationships with stakeholders across the division.
• Manage multiple projects concurrently under supervision.
• Continue to build technical expertise and professional development, contributing to innovative problem-solving and product development.

Qualifications

• Education: Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a related technical discipline.
• Experience: Preferred minimum: 1–2 years of experience with a technical bachelor’s degree, or 0–2 years with a master’s degree.
• Skills and Knowledge: Understanding of systems engineering methodologies; experience with electromechanical design and embedded software development, ideally within the medical device field; experience with systems integration across electrical, mechanical, and software components; knowledge across multiple engineering disciplines; strong critical thinking, analytical, and problem-solving skills; familiarity with physical and mathematical modeling tools; knowledge of medical device regulations and standards, including: FDA QSR, ISO 13485, ISO 14971, IEC 60601‑1 and IEC 60601‑1‑2, IEC 62304 (software lifecycle for medical devices); experience with Product Lifecycle Management (PLM) systems; strong communication, teamwork, and collaboration skills; experience with technical documentation and presentations; project management skills; SolidWorks experience is a plus.