Senior Systems Engineer - Medical Device NPI

HCL Technologies Limited; California; On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid time off

Paid holidays

Job summary

HCL Technologies Limited is seeking a Senior Systems Engineer for new product development in California. You will lead systems engineering activities for Siemens Varian radiation therapy equipment, translating VOC inputs from clinical users, marketing and manufacturing into system requirements and architecture.

You will de-risk ideas through prototyping or simulations, define interfaces across electrical, mechanical, software and control subsystems, and drive verification strategies, regulatory

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.

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

System architecture

Requirements engineering

Subsystem interfaces

System integration

Risk management

Hardware experience

Software/embedded systems

Investigations leadership

Communication

R&D teamwork

Tools

JAMA

Job description

HCL Technologies Limited is seeking a Senior Systems Engineer for new product development in California. You will lead systems engineering activities for Siemens Varian radiation therapy equipment, translating VOC inputs from clinical users, marketing and manufacturing into system requirements and architecture.

You will de-risk ideas through prototyping or simulations, define interfaces across electrical, mechanical, software and control subsystems, and drive verification strategies, regulatory