Systems Engineer – Medical Devices

Location: Pune

Experience: 5–10 years

Domain: Medical Devices

Notice Period: Immediate to a maximum of 60 days

Key Responsibilities

• Demonstrate strong expertise in systems engineering and requirements management.
• Interpret Technical System Requirements and translate them into detailed Subsystem/Unit requirements.
• Possess basic understanding of regulatory compliances and relevant standards for medical products.
• Have foundational domain knowledge across Electronics / Electrical / Embedded / Software / Mechanical Design.
• Provide excellent documentation and reporting.
• Collaborate effectively with cross-functional teams.
• Coordinate with external test laboratories to validate products against applicable standards and requirements.
• Maintain a solid understanding of software and hardware systems architecture.
• Develop Technical System Requirements, review them with a cross-functional team, and maintain updates in DOORS (Requirement Management Tool).
• Ensure traceability across TSRs, TSSRs, and risk files.
• Apply knowledge of ISO 14971 and the risk management process.
• Have basic or expert understanding of regulatory standards and determine applicable requirements to update system documentation.
• Use knowledge of FMEA to drive system-level DFMEA and cascade it to the subsystem level.
• Execute system-level medical device verification activities, including test case writing, review, and execution.
• Prepare documentation needed for regulatory submissions, ensuring alignment with applicable medical device regulations.
• Understand system integration plans, testing activities, and reporting outputs.