System Engineer

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

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 R&D;, Quality, Regulatory Affairs, Clinical, Service, and Operations to resolve technical challenges and deliver robust product solutions.

Contribute to full product lifecycle management, recent product development, product improvements, complaint investigations, CAPA, and lifecycle, while developing deeper expertise in system engineering, risk management, and medical imaging.

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. (Experience with healthcare systems, medical imaging, design controls, or regulatory compliance is preferred.For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

Are you ready to do the work of your life to help the lives of others Learn more about , discover and learn more about .

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.

📌 System Management Engineer (Pune)
🏢 Respironics
📍 Pune