Senior System Engineer

Lead system engineering activities for the new product development of Siemens Varian Radiation Therapy equipment

• Translate VOC (clinical, end users, marketing, manufacturing, service & other Siemens product stakeholder's product needs) into system and subsystem requirements.

• Develop system architecture, functional decomposition and system specifications. Prepare and facilitate make/buy decisions

• Perform requirements flow-down and bidirectional traceability from system to subsystem level

. • Identify product technical risks and propose/derive the mitigation plans

• Define and manage interfaces across electrical, electronics, mechanical, software, firmware and control subsystems. Coordinate and resolve any technical issues/conflicts

• Lead/support system integration, bring-up and performance characterization of prototypes and engineering builds.

• Define system operating modes, safety mechanisms, interlocks, fault handling and system responses.

• Perform/support system risk analysis, PHA, System FMEA, DFMEA and risk-control definition.

• Participate in design reviews, architecture reviews, risk reviews and technical decision-making.

• Develop/support system verification strategy, test plans, protocols and acceptance criteria.

• Support system-level verification, validation, troubleshooting and root-cause analysis.

• Ensure design compliance with applicable medical-device quality, safety and regulatory requirements.

• Extensive working knowledge of ISO 13485, ISO 14971, IEC 60601 family, IEC 62304 and IEC 62366-1 preferred.

• Prior working experience in Radiation Therapy/Radiation Oncology systems, medical LINACs, imaging, beam delivery or patient-positioning systems will be beneficial.

• Experience with safety-critical, real-time and multidisciplinary electromechanical systems preferred.

• Support DHF documentation, regulatory submission activities and design transfer to manufacturing.

• Collaborate with R&D, Quality, Regulatory, Manufacturing, Clinical and supplier teams throughout product development.

• Ability to work effectively in a fast-paced, multidisciplinary R&D environment with evolving requirements.

• BS/MS in Electrical or Systems Engineering or related discipline with 10 - 15+ years of relevant experience as system engineer for complex electromechanical products new design or major redesigns.

• Medical devices, instrumentation, robotics, imaging, or regulated product development experience is preferred. System Integrator Key Responsibilities