System Engineer
- Pune, India
- Mid Level
- 5+ years
- Posted
Skills
Required
- system engineering / product development / lifecycle management
- requirements engineering
- system design
- system interface management
- verification and validation
- FTA
- root-cause analysis
- Electrical
- Electronics
- Mechanical
Preferred
- interfaces
- design solutions
- integration
- validation
- lifecycle changes
- hazard analysis
- risk-control definition
- ISO
- IEC62304
System Engineer Job Description Lead system engineering and product risk management activities to develop safe, reliable, and compliant Diagnostic X-ray solutions that improve patient care.
About Philips
- Philips Are you ready to do the work of your life to help the lives of others?
- Learn more about our business , discover our rich and exciting history and learn more about our purpose .
- If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
- You may still be the right candidate for this or other opportunities at Philips.
- Learn more about our culture of impact with care . #LI=PHILIPS
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 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, while developing deeper expertise in system engineering, risk management, and medical imaging.
Requirements
- 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.
- 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.
- 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.ou can make a clear, informed decision.
Benefits include
How we work together We believe that we are better together than apart. 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.
