Job Title: Systems Engineer Medical Devices
Experience: 5-10 Years
Location: Pune Viman Nagar

Notice: Immediate

Budjet -10 LPA
Employment Type: Full-Timex

Job Description:

We are looking for an experienced Systems Engineer with strong expertise in Systems Engineering, Requirements Management, System Architecture, Verification, Risk Management, and Medical Device Compliance.

The ideal candidate should have hands-on experience in developing and managing Technical System Requirements (TSR), flowing requirements down to Technical Sub-System Requirements (TSSR), and maintaining end-to-end traceability with Risk Management Files and verification activities.

Experience in Medical Device Product Development, IBM DOORS, ISO 14971, FMEA/DFMEA, and coordination with external test laboratories will be highly preferred.

Key Skills & Competencies
- Proficiency in Systems Engineering and Requirements Management.
- Robust understanding of Technical System Requirements (TSR) and the ability to effectively flow down requirements into detailed Subsystem and Unit-level Requirements.




- Good understanding of Software and Hardware System Architecture.
- Basic domain knowledge in:
- Electronics
- Electrical Engineering
- Embedded Systems
- Software Development
- Mechanical Design
- Excellent documentation, reporting, and communication skills.
- Strong collaboration skills with the ability to work effectively in cross-functional teams.
- Experience coordinating with external test laboratories for compliance testing and certification activities.

Regulatory & Risk Management Knowledge
- Understanding of regulatory compliances and applicable standards for Medical Devices.
- Knowledge of ISO 14971 and Medical Device Risk Management processes.
- Ability to identify applicable regulatory requirements and update system documentation accordingly.
- Basic to expert knowledge of relevant medical device regulatory standards.
- Understanding of FMEA methodologies, including:
- System-level DFME

📌 System Engineer (Pune)
🏢 FRobin Technologies
📍 Pune