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 stakeholders 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

Required Skills:

PHASystem FMEADFMEARisk ControlIEC 60601ISO 14971ISO 13485IEC 62304