Position: Systems Engineer – Medical Device R&D; / Systems Integration

Experience: 4 – 8 years

Role Overview The Systems Engineer will act as the technical integrator across Mechanical, Electrical, Software, Hardware, Product Management, Quality and Regulatory functions , translating user needs into system requirements, architecture, interfaces, risk controls and verification/validation activities.

Key Responsibilities
Capture and analyze user needs and product requirements .
Develop System Requirements Specifications.
Decompose system requirements into subsystem requirements.
Establish and maintain requirements traceability .
Define system architecture and subsystem interfaces.
Coordinate Mechanical, Electrical, Software and other engineering disciplines.
Support HW/SW/Mechanical integration.
Lead or participate in system design reviews.
Develop system-level specifications.




Perform system-level risk assessments.
Support Hazard Analysis, FMEA and Risk Management .
Define risk controls and verify their implementation.
Develop system V&V; strategies.
Develop verification protocols and reports.
Support design validation activities.
Analyze system-level failures and integration issues.
Drive cross-functional technical problem resolution.
Support product cybersecurity / security-by-design activities where applicable.
Support design transfer and manufacturability/testability.
Support DHF and regulatory documentation.
Support regulatory submissions.
Manage requirements and technical changes.
Coordinate with external engineering/development partners.
Support product commercialization.

📌 Systems Engineer Coimbatore
🏢 NovintiX
📍 Coimbatore