System Engineer

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.

• Strong 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 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.