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 positive 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