Lead Medical Systems Engineer – NPD

Varian Medical Systems, Inc.; United States; On-site; USD 193,000 - 265,000; Full time

Benefits offered by this job

medical insurance

dental insurance

vision insurance

401(k) retirement plan.

life insurance

long-term and short-term disability 보험

Job summary

Siemens Healthineers is seeking a Senior Systems Engineer for New Product Development in the United States. You will lead systems engineering for radiation therapy equipment, translating VOC inputs into robust requirements and driving cross-functional design decisions.

The role emphasizes system architecture, verification, and risk management across electrical, mechanical, software, and software/firmware domains.

Qualifications

• 10–15+ years of relevant systems engineering experience in complex electromechanical product development.
• Strong experience in system architecture, requirements engineering, and verification.
• Hands-on experience with multidisciplinary hardware, software and embedded systems.
• Ability to independently lead complex technical investigations and cross-functional decisions.
• Experience with requirements management tools such as JAMA or equivalent.
• Strong communication, 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, LINACs, imaging or related regulated environments.
• Experience with safety-critical, real-time electromechanical systems.

Responsibilities

• Lead systems engineering activities for new product development of Siemens Varian radiation therapy equipment.
• Translate VOC inputs from clinical users, marketing, manufacturing, service and other stakeholders into system and subsystem requirements.
• Develop system architecture, functional decomposition and system specifications; de-risk ideas by prototyping or simulations; support make/buy decisions.
• Perform system analysis and impact analysis for key features of the system.
• Maintain bidirectional traceability among user needs, clinical workflow, system and subsystem requirements.
• Own system-level technical decisions, identify risks and drive mitigation plans to closure.
• Define and manage interfaces across electrical, electronics, mechanical, software, firmware and control subsystems; resolve cross-functional issues.
• Lead or support system integration, prototype bring-up and performance characterization of 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 DHF documentation, regulatory submissions and manufacturing design transfer.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Clinical and supplier teams throughout product development.

Job description

Siemens Healthineers is seeking a Senior Systems Engineer for New Product Development in the United States. You will lead systems engineering for radiation therapy equipment, translating VOC inputs into robust requirements and driving cross-functional design decisions.

The role emphasizes system architecture, verification, and risk management across electrical, mechanical, software, and software/firmware domains.