Senior Medical Systems Engineer - NPI & Integration

HCL Technologies Limited; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

HCLTech is seeking a Senior Systems Engineer for New Product Development in San Diego, California. You will lead multidisciplinary systems engineering for Siemens Varian radiation therapy equipment, translating VOC inputs into robust system requirements, architectures, and verification plans.

The role involves design reviews, risk management, and cross-functional collaboration across R&D, Regulatory, Manufacturing and suppliers.

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.

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.

Skills

Systems engineering

Requirements engineering

System architecture

Risk management

Cross-functional collaboration

Hands-on hardware/software

Embedded systems

Technical leadership

Tools

JAMA

Job description

HCLTech is seeking a Senior Systems Engineer for New Product Development in San Diego, California. You will lead multidisciplinary systems engineering for Siemens Varian radiation therapy equipment, translating VOC inputs into robust system requirements, architectures, and verification plans.

The role involves design reviews, risk management, and cross-functional collaboration across R&D, Regulatory, Manufacturing and suppliers.