Job Title: Systems Engineer Medical Devices

Experience: 5-10 Years

Location: Pune Viman Nagar

Notice: Immediate

Budjet -10 LPA

Employment Type: Full-Timex

:

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.
- Strong understanding of Technical System Requirements (TSR) and the ability to effectively flow down requirements into detailed Subsystem and Unit-level Requirements.
- Valuable 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 DFMEA
- Flow-down of risks to subsystem-level DFMEA
- Ability to maintain traceability between:

- Technical System Requirements (TSR)
- Technical Sub-System Requirements (TSSR)

- Risk Management Files

Key Responsibilities

- Author, review, and maintain Technical System Requirements in collaboration with cross-functional engineering teams.
- Update and manage requirements in IBM DOORS (Requirements Management Tool).
- Drive end-to-end traceability from system requirements through subsystem requirements and risk documentation.
- Perform system-level verification activities, including:

- Test case creation

- Test review

- Test execution

- Test reporting
- Develop and maintain System Integration Plans, test strategies, and integration reports.
- Support preparation of documentation for regulatory submissions, ensuring compliance with applicable medical device regulations.
- Collaborate with engineering, quality, regulatory, and verification teams to ensure successful product development and compliance.

Preferred Experience

- Experience in Medical Device Product Development.
- Exposure to requirements management tools such as IBM DOORS.
- Hands-on experience in system verification, risk management, and regulatory compliance activities.
- Familiarity with medical device standards and product lifecycle documentation.

📌 System Engineer (Pune)
🏢 FRobin Technologies
📍 Pune