System Engineer

Job Summary

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

Responsibilities

• 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, risk-control definition, in compliance with applicable medical-device standards such ISO 13485, ISO 14971, IEC62304 and the IEC 60601 series.
• Collaborate with global, cross-functional teams across RD, 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, while developing deeper expertise in system engineering, risk management, and medical imaging.

You're the right fit if:

• Experience: You have 5 to 8 years of experience in system engineering, product development, or lifecycle management, preferably within medical devices, or another regulated industry.
• Skills: You have experience in requirements engineering, system design, system interface management, verification and validation, risk management, and structured problem-solving methods such as FMEA, FTA, and root-cause analysis.
• Education: You hold a minimum B. Tech degree in Electrical, Electronics, Biomedical, Mechanical, or a related engineering discipline. (M. Tech is preferred)
• Mandatory: Working knowledge of ISO 13485, ISO 14971, IEC 62304, and the applicable IEC 60601 series
• Experience with healthcare systems, medical imaging, design controls, or regulatory compliance is preferred.

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