Senior System Engineer

Zenith Services Inc.; Palo Alto (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Zenith Services Inc. is seeking a Lead System Engineer for the development of Siemens Varian Radiation Therapy equipment.

The role focuses on translating clinical and stakeholder needs into system requirements, and coordinating architecture, risk management, and interface definitions across electromechanical subsystems. You will lead system integration, verification planning, and collaboration with R&D, Quality, Regulatory, and Manufacturing to ensure robust design transfers and regulatory

Qualifications

• Translate VOC into system/subsystem requirements.
• Develop system architecture and functional decomposition.
• Perform requirements flow-down and bidirectional traceability.
• Identify technical risks and mitigation plans.
• Define and manage interfaces across subsystems.

Responsibilities

• Lead system engineering for Siemens Varian Radiation Therapy equipment.
• Coordinate with electrical, mechanical, software, and software teams.
• Define operating modes, safety interlocks and fault handling.
• Lead system integration, bring-up and performance characterization.
• Support design reviews, risk reviews and technical decisions.
• Develop verification strategy, test plans and acceptance criteria.
• Ensure compliance with ISO 13485, IEC 60601 and related standards.

Skills

Systems engineering

Requirements traceability

System architecture

Risk analysis

Interface management

Verification planning

Regulatory awareness

Education

BS/MS in Electrical or Systems Engineering

Job description

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