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

Experience: 5–6 / 8–10 / 10+ Years

Role Summary:

We are looking for a Systems Engineer to support medical-device product development and act as a technical integrator across Mechanical, Electrical, Software, Quality, Regulatory, and Product Management teams.

Key Responsibilities:

- Capture and translate user needs and product requirements into system requirements.
- Develop and maintain requirements specifications and traceability.
- Define system architecture and subsystem interfaces.
- Support HW/SW/mechanical integration and system-level testing.
- Perform risk management, Hazard Analysis, and FMEA.
- Support Design Controls, DHF, Verification & Validation (V&V;).
- Participate in design reviews and resolve system-level technical issues.
- Support regulatory documentation, design transfer, and product commercialization.
- Manage technical changes and coordinate with cross-functional and external teams.





Required Skills:

- Degree in Systems, Electrical, Mechanical, Biomedical Engineering, or related field.
- Experience in medical-device/product development preferred.
- Robust knowledge of Requirements Engineering, System Architecture, Risk Management, and V&V.;
- Experience with DOORS, Jama, Polarion, or similar tools.
- Knowledge of ISO 14971, ISO 13485, FDA Design Controls, and IEC 60601.
- Experience with FMEA, Design Controls, DHF, and technical documentation.
- Cybersecurity / IEC 62304 exposure is an advantage.

Senior-Level Expectations

8–10 Years: System architecture, requirements ownership, integration, risk and V&V; leadership.

10+ Years: System architecture ownership, technical strategy, cross-functional leadership, governance, and regulatory support.

📌 System Engineer (Hyderabad)
🏢 NovintiX
📍 Hyderabad