System Engineer

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.
• 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.

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.