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.