Senior Systems Engineer - New Product Development

Job Summary

Senior Systems Engineer - New Product Development

• Lead systems engineering activities for new product development of Siemens Varian radiation therapy equipment.
• Translate Voice of Customer (VOC) inputs from clinical users, marketing, manufacturing, service and other stakeholders into system and subsystem requirements.
• Develop system architecture, functional decomposition and system specifications. Help de-risk ideas and technical decisions by prototyping or simulations. Support make/buy technical decisions.

Key Responsibilities

• Lead systems engineering activities for new product development of Siemens Varian radiation therapy equipment.
• Translate Voice of Customer (VOC) inputs from clinical users, marketing, manufacturing, service and other stakeholders into system and subsystem requirements.
• Develop system architecture, functional decomposition and system specifications. Help de-risk ideas and technical decisions by prototyping or simulations. Support make/buy technical decisions.
• Perform System Analysis and Impact analysis for the key features of the system.
• Maintain bidirectional traceability among user needs list, clinical workflow, system and subsystem requirements.
• Own system-level technical decisions, identify product risks and drive mitigation plans to closure.
• Define and manage interfaces across electrical, electronics, mechanical, software, firmware and control subsystems. Resolve cross-functional technical issues.
• Lead or support system integration, prototype bring-up and performance characterization of engineering builds.
• Define system operating modes, safety mechanisms, interlocks, fault handling and system responses.
• Review system risk analysis, PHA, System FMEA, DFMEA and risk-control definition.
• Participate in design reviews, architecture reviews, risk reviews and technical decision-making.
• Develop system verification strategies, test plans, protocols and acceptance criteria.
• Support system-level verification, validation, troubleshooting and root-cause analysis.
• Drive complex electromechanical product development from concept through integration, verification and design transfer.
• Support Design History File (DHF) documentation, regulatory submissions and manufacturing design transfer.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Clinical and supplier teams throughout product development.

Skill Requirements

• 10-15+ years of relevant systems engineering experience in complex electromechanical product development or major product redesigns.
• Strong experience in system architecture, requirements engineering, subsystem interfaces, system Integration and verification, risk management reviews.
• Hands-on experience with multidisciplinary hardware, software and embedded systems.
• Ability to independently lead complex technical investigations and drive cross-functional engineering decisions.
• Experience with requirements management and traceability tools such as JAMA or equivalent.
• Strong communication, technical leadership and problem-solving skills.
• Ability to work effectively in a fast-paced, multidisciplinary R&D environment.

• Working knowledge of ISO 13485, ISO 14971, IEC 60601 family, IEC 62304 and IEC 62366-1.
• Experience in medical devices, radiation therapy, radiation oncology systems, medical LINACs, imaging, beam delivery or patient-positioning systems or other regulated product development environments.
• Experience with safety-critical, real-time, multidisciplinary electromechanical systems.

Other Requirements