Company: Will Ware Technologies
Role: System engineer
Experience: 6+ Years
Location: Pune
Work Mode: Onsite

Job Description:

Important points to be Noted:

- /M. Tech/B.E/MSC/MCA - Electronics/software/Electrical (No mechanical)
- Medical device domain experience (Mandatory)
- ISO 14971 Risk Management experience (Mandatory)
- Requirements management & RTM (Mandatory)
- Regulatory compliance exposure (ISO 13485/IEC 62304/FDA/MDR) (Mandatory)
- System Engineering-Product development lifecycle experience (Mandatory)
- Software development/embedded systems experience (Preferred)
- V&V;/System Testing experience (Preferred)
- DOORS/Polarion/Jama tool exposure (Preferred)

Key Skills & Competencies

- Proficiency in Systems Engineering and Requirements Management.
- Solid 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.

📌 System engineer (India)
🏢 WILLWARE TECHNOLOGIES PRIVATE
📍 India