Location: Pune Experience: 5–10 years Domain: Medical Devices Notice Period: Immediate to a maximum of 60 days Key Responsibilities Proficiency in systems engineering and requirements management. Understand Technical System Requirements and effectively flow them down into detailed Subsystem/Unit requirements. Basic understanding of regulatory compliances and applicable standards for medical products. Basic domain knowledge of Electronics / Electrical / Embedded / Software / Mechanical Design. Excellent documentation and reporting skills. Collaborate effectively with cross-functional teams. Coordinate with external test labs for testing against applicable standards/requirements. Maintain a valuable understanding of software and hardware systems architecture. Write Technical System Requirements, review them with a cross-functional team,



and update them in DOORS (Requirement Management Tool). Drive traceability between TSRs, TSSRs, and risk files. Apply good knowledge of ISO 14971 and the risk management process. Possess basic or expert knowledge of regulatory standards and identify applicable requirements to update system documents. Apply basic knowledge of FMEA and drive system-level DFMEA, cascading it down to the subsystem level. Perform system-level medical device verification, including test case writing, review, and execution. Prepare documentation for regulatory submissions, ensuring compliance with applicable medical device regulations. Understand system integration plans, testing, and reporting.

📌 Systems Engineer – Medical Devices (Pune)
🏢 Tata Elxsi
📍 Pune