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