System Engineer

NovintiX; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

NovintiX is seeking 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. The role emphasizes system requirements, architecture, and risk management across disciplines.

The candidate will drive V&V leadership, ensure regulatory alignment (ISO 14971, ISO 13485, FDA Design Controls) and coordinate with cross-functional and external teams to deliver robust

Qualifications

• Engineering degree required in systems/electrical/mechanical/biomedical domains.
• Strong knowledge of requirements, architecture, risk management, and V&V.
• Familiarity with regulatory standards (ISO 14971, 13485; FDA Design Controls).
• Experience with FMEA, DHF and design documentation.

Responsibilities

• Capture and translate user needs into system requirements and interfaces.
• Develop and maintain system requirements, traceability, and validation plans.
• Define system architecture and interfaces between subsystems.
• Support integration across hardware, software, mechanical domains.
• Lead risk management, hazard analysis, and FMEA activities.
• Participate in design reviews and resolve system-level issues.
• Support regulatory documentation, design transfer, and product commercialization.

Skills

Requirements Engineering

System Architecture

Risk Management

Verification & Validation

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Systems/Electrical/Mechanical/Biomedical Engineering

Tools

DOORS

Jama

Polarion

Job description

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.
• 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.
• Strong 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.

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.