Sr. Systems Engineer

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

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Realizes the functional concept of systems in a project by technical detailed solutions.

Senior Systems Engineer - New Product Development

Experience: 10-15+ years

Education: BS/MS in Electrical Engineering, Systems Engineering, or a related discipline.

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.

Required Qualifications

• 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.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

The base pay range for this position is:

$192,600 - $264,825

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

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Export Control:

A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

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