Systems Engineer - Medical Devices

About F. Robin Technologies

F. Robin Technologies is a comprehensive technology and manufacturing company focusing on PCB Design, Electronics Manufacturing Services, Semiconductor Support, and Engineering Services. Based in Madurai with offices in Chennai and Bengaluru, the company delivers complete product development and manufacturing solutions to global clients, covering stages from schematic design to production support while emphasizing innovation, quality, and affordability.

Job Overview

We seek an experienced Systems Engineer specialized in Medical Devices, with 5-10 years' experience, located in Pune Viman Nagar. The role demands expertise in Systems Engineering, Requirements Management, System Architecture, Verification, Risk Management, and compliance to Medical Device standards. Immediate joining is expected with a budgeted annual salary up to 10 LPA.

Key Responsibilities

• Develop, review, and maintain Technical System Requirements in partnership with multidisciplinary engineering teams.
• Manage and update requirements using IBM DOORS tool.
• Ensure comprehensive traceability between system requirements, subsystem requirements, and risk management documentation.
• Conduct system-level verification tasks including creation, review, execution, and documentation of test cases.
• Prepare and sustain System Integration Plans, test strategies, and generate integration reports.
• Assist in preparing regulatory submission documents adhering to medical device compliance requirements.
• Collaborate with engineering, quality, regulatory, and verification units to support successful product development and certification processes.

Required Skills and Competencies

• Strong foundation in Systems Engineering and effective Requirements Management capabilities.
• Expertise in formulating Technical System Requirements (TSR) and breakdown into subsystem and unit-level requirements.
• Sound knowledge of Software and Hardware System Architecture fundamentals.
• Familiarity with electronics, electrical engineering, embedded systems, software development, and mechanical design domains.
• Excellent skills in documentation, reporting, communication, and cross-functional teamwork.
• Experience liaising with external test laboratories for compliance testing and certification.

Regulatory and Risk Management Expertise

• Understanding medical device regulatory standards particularly ISO 14971 risk management process.
• Ability to map and update system documentation per applicable regulatory requirements.
• Proficient in FMEA including system and subsystem DFMEA and maintaining traceability between TSR, TSSR, and risk files.

Preferred Experience

• Prior involvement in medical device product development lifecycle.
• Proficiency using IBM DOORS or similar requirements management tools.
• Hands-on experience with system verification, risk and regulatory compliance activities.
• Understanding of medical device standards and product lifecycle documentation practices.

Additional Information

Location: Pune, India (Viman Nagar)
Employment type: Full-time
Experience required: 5-10 years
Salary: Up to 10 Lakh INR per annum
Notice period: Immediate requirement
Eligibility: Open to any graduate