Senior Systems Engineer: Medical Device NPD Leader

Siemens Healthineers AG; Palo Alto (CA); 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

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers AG in Palo Alto is seeking a Senior Systems Engineer for New Product Development. The role focuses on end-to-end systems engineering for electromechanical medical devices, translating clinical and stakeholder inputs into robust system requirements and architecture.

You will drive risk-based design decisions, lead cross-functional teams, and contribute to regulatory documentation and design transfer while advancing complex radiotherapy technology development.

Qualifications

• 10-15+ years of systems engineering experience in complex electromechanical product development or major redesigns.
• Strong experience in system architecture and requirements engineering.
• Hands-on experience with hardware, software and embedded systems.
• Ability to independently lead complex technical investigations and cross-functional decisions.
• Experience with requirements management and traceability tools such as JAMA.
• Strong communication, technical leadership and problem solving.
• Ability to work in a fast-paced, multidisciplinary R&D environment.
• Working knowledge of ISO 13485, ISO 14971, IEC 60601 family, IEC 62304 & IEC 62366-1.
• Experience with medical devices, radiation therapy, or regulated product development environments.

Responsibilities

• Lead systems engineering activities for new product development of Siemens Varian radiotherapy equipment.
• Translate VOC inputs from clinical users and stakeholders into system requirements.
• Develop system architecture and specifications; prototype or simulate to de-risk ideas; support make/buy decisions.
• Perform system and impact analyses for key features of the system.
• Maintain bidirectional traceability among needs, workflow and requirements.
• Own system-level decisions, identify risks and drive mitigations to closure.
• Define and manage interfaces across subsystems and resolve cross-functional issues.
• Lead or support system integration, prototype bring-up and performance characterization.
• Define operating modes, safety mechanisms, interlocks, fault handling and responses.
• Review risk analyses (PHA, FMEA) and risk-control definitions.
• Participate in design, architecture, risk reviews and technical decisions.
• Develop system verification strategies, test plans, protocols and acceptance criteria.
• Support system verification, validation, troubleshooting and root-cause analysis.
• Drive electromechanical product development from concept to transfer; support DHF documentation & regulatory submissions.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Clinical and supplier teams.

Skills

Systems engineering

Architecture

Requirements engineering

Subsystem interfaces

Risk management

Verification

Prototype & simulations

Cross-functional leadership

Multidisciplinary hardware

Education

BS/MS in Electrical Engineering or Systems Engineering

Tools

JAMA

Job description

Siemens Healthineers AG in Palo Alto is seeking a Senior Systems Engineer for New Product Development. The role focuses on end-to-end systems engineering for electromechanical medical devices, translating clinical and stakeholder inputs into robust system requirements and architecture.

You will drive risk-based design decisions, lead cross-functional teams, and contribute to regulatory documentation and design transfer while advancing complex radiotherapy technology development.