System Engineer

Overview

Lead system engineering and product risk management activities to develop safe, reliable, and compliant Diagnostic X-ray solutions that improve patient care.

What you'll do

• Define and manage system requirements, interfaces, design solutions, and traceability across product development, integration, verification, validation, and lifecycle changes.
• Lead system-level risk management activities, including hazard analysis, FMEA, and risk-control definition, in compliance with applicable medical-device standards such as ISO 13485, ISO 14971, IEC 62304, and the IEC 60601 series.
• Collaborate with global, cross-functional teams across R&D, Quality, Regulatory Affairs, Clinical, Service, and Operations to resolve technical challenges and deliver robust product solutions.
• Contribute to full product lifecycle management, new product development, product improvements, complaint investigations, CAPA, and lifecycle activities.

What you'll need

• 5 to 8 years of experience in system engineering, product development, or lifecycle management, preferably within medical devices or another regulated industry.
• Experience in requirements engineering, system design, system interface management, verification and validation, and risk management.
• Experience with structured problem-solving methods such as FMEA, FTA, and root-cause analysis.
• Minimum B.Tech degree in Electrical, Electronics, Biomedical, Mechanical, or a related engineering discipline.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, and the applicable IEC 60601 series.

Nice to have

• M.Tech degree.
• Experience with healthcare systems, medical imaging, design controls, or regulatory compliance.

Details

• Location: Pune.
• Office-based teams work in person at least 3 days per week.