Subject Matter Expert - System Engineer

Experience 5 Years

Location Pune

Mode Hybrid

Role subject matter experts who has Proficiency in systems engineering and requirements management.

KEY Skills Preferred

Understands Technical System Requirements well and effectively flows down them down into detailed Subsystem/Unit requirements.

Good understanding of software and hardware systems architecture.

Write Technical system requirements review with a crossfunctional team and update in Doors (Requirement Management Tool)

Drive traceability between TSR to TSSRs and Risk files.

Good knowledge of ISO 14971 Risk management process

Basic or Expert knowledge about Regulatory standards and identifying applicable requirements to update System documents.

Basic knowledge about Electronics / Electrical / Mechanical and SW Design.

Basic knowledge of FMEA and drive DFMEA system level and drive down to subsystem level.

Verification of Medical device at system level Test case writing review and execution.

Prepare documentation for regulatory submissions ensuring compliance with applicable medical device regulations.

Understanding of System integration plan and test and reporting.

Excellent documentation and reporting skills.

Collaborative and able to work with crossfunctional teams.

Good at coordination with External test labs for testing of applicable standards/requirements

Tool: DOORs JIRA ClearQuest HP ALM Any PLM tools Requirement management tools

Remote Work :

No