System Engineer
Lead system engineering and product risk management activities to develop safe, reliable, and compliant Diagnostic X-ray solutions that improve patient care.
- Pune, Maharashtra, India
- On-site
- Posted Nov 10, 2026
INDUSTRYEngineeringMechanical EngineeringElectrical Engineering
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
- 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
Requirements
- Bachelor's degree in Electrical, Electronics, Biomedical, Mechanical, or a related engineering discipline
- Experience in a medical devices
- Experience in a regulated industry
Nice to have: M.Tech, experience with healthcare systems, medical imaging, design controls, regulatory compliance
Skills
requirements engineeringsystem designsystem interface managementverification and validationrisk managementFMEAFTAroot-cause analysisISO 13485ISO 14971IEC 62304IEC 60601 series
Full description
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