System Engineer - Medical Devices

Proficiency in systems engineering and requirements management.

Understands Technical System Requirements well and effectively flows down 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 / SW / Mechanical Design.

Excellent documentation and reporting skills.

Collaborative and able to work with cross-functional teams.

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

Good understanding of software and hardware systems architecture.

Write Technical system requirements, review with a cross-functional team, and update in Doors (Requirement Management Tool)

Drive traceability between TSR to TSSR's 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 of FMEA and drive DFMEA system level and drive down to sub-system 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.