Company DescriptionA global leader in medical technology and innovation is seeking a Senior Systems Engineer – Products & Systems to join its IGT Systems organization within the Patient Safety & Quality domain. The company develops advanced imaging and therapy technologies that improve clinical outcomes worldwide.Operating in a highly regulated environment, the organization works in compliance with FDA (21 CFR 820), ISO 13485, EU MDR, and IEC standards, embedding safety, reliability, and compliance into complex system designs across the full product lifecycle.Role OverviewAs a Senior Systems Engineer, you will play a key role in the end-to-end development of complex medical device systems, from concept and requirements definition through integration, verification, validation, and post-market feedback.You will act as a technical integrator and systems-level advisor, working closely with R&D, hardware, software, V&V, and quality/regulatory teams to ensure that system architecture, interfaces, and requirements result in safe, reliable, and compliant products.While the role operates within a regulated quality framework, the primary focus is systems engineering, integration, and lifecycle thinking, rather than traditional quality assurance.Key ResponsibilitiesSystems Engineering & IntegrationDefine, manage, and maintain system-level requirements, interfaces, and functional architectures for complex medical devices.Lead requirements decomposition, traceability, and change impact analysis across hardware, software, and mechanical domains.Drive system integration activities, ensuring alignment between subsystems and overall product performance objectives.Verification, Validation & ReliabilityPartner closely with Verification & Validation teams to define system-level test strategies covering performance, safety, reliability, and usability-related risks.Support validation of key system characteristics, ensuring appropriate coverage, confidence, and robustness.Analyze system-level failures and field data to identify improvement opportunities and drive design updates.Risk, Safety & Regulatory InterfaceContribute to system-level risk management activities (e.g., FMEA, hazard analysis) in line with ISO 14971.Ensure system designs and technical decisions align with regulatory and design control expectations without owning QA execution.Support design reviews by providing systems-level technical input related to safety, reliability, and integration.Lifecycle & Post-Market FeedbackCollaborate with post-market, service, and reliability teams to assess real-world system performance.Use field data and feedback to support continuous improvement of system architecture and requirements.Essential RequirementsBachelor’s (5+ years) or Master’s (3+ years) degree in Systems, Mechanical, Electrical, Mechatronics, or related Engineering discipline.Proven experience in systems engineering, integration, or V&V within medical devices, high-tech, robotics, aerospace, or similar regulated industries.Strong understanding of requirements engineering, system architecture, and interface management.Hands-on experience working in ISO 13485 / FDA-regulated environments.Familiarity with risk management methodologies (FMEA, hazard analysis, fault analysis).Experience collaborating with cross-functional R&D teams across hardware, software, and mechanical domains.Strong analytical, problem-solving, and root cause analysis skills.Excellent communication and documentation skills.Nice to HaveExposure to IEC 60601, IEC 62304, IEC 62366.Experience with model-based systems engineering (MBSE) or structured systems tools.Background in robotics, autonomous systems, or complex electromechanical products.Experience supporting DHF-related technical documentation (without full QA ownership).Work ModelHybrid role with minimum 3 days per week onsite.Why This RoleWork on high-impact, safety-critical medical systems with global clinical reachStrong technical ownership and systems influence, without being a pure quality roleExposure to full product lifecycle, from concept through post-market learningCollaborative, multidisciplinary engineering environment