System Engineer

Philips; Pune District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Philips is seeking a System Engineer to lead system engineering and risk management for Diagnostic X-ray solutions. The role focuses on defining requirements, interfaces and traceability across development, integration, verification and validation, ensuring compliance with ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series.

You will collaborate with global teams across R&D, Quality, Regulatory Affairs, Clinical, Service and Operations to deliver safe, reliable medical imaging products.

Qualifications

• Experience in system engineering within medical devices or regulated industries.
• Knowledge of requirements engineering, design, interfaces, verification, validation and traceability.
• Proficient in risk management with methods such as FMEA, FTA, and problem-solving techniques.

Responsibilities

• Define and manage system requirements, interfaces, designs and traceability across development lifecycle.
• Lead system-level risk management activities including hazard analysis and risk-control definitions.
• Collaborate with R&D, Quality, Regulatory, Clinical, Service and Operations to resolve technical challenges.
• Contribute to full product lifecycle management and regulatory compliance.

Skills

Requirements engineering

System design

System interface management

Verification & validation

Risk management

FMEA

FTA

Root-cause analysis

Education

B.Tech in Electrical, Electronics, Biomedical, Mechanical or related engineering (M.Tech preferred)

Job description

Job Title

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.

Your role:

• 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.

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.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.

About 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.

Learn more about our culture of impact with care.

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