Job Title: System Engineer Department: System Engineering – Research & Development

Location:
Hyderabad

Experience:
4–6 years

Education:
Bachelor’s or higher degree in Biomedical Engineering or Systems Engineering. A Master’s degree is an added advantage. Role OverviewWe are looking for a System Engineer with experience in medical device R&D; to support system architecture, requirements management, system integration, and verification and validation activities. The candidate will work with cross-functional engineering teams to ensure medical device systems meet functional, performance, safety, quality, and regulatory requirements.

Key Responsibilities
• Support the design and development of medical device system architectures integrating mechanical, electrical, hardware, software, and embedded subsystems.
• Define and maintain system requirements, specifications, interface definitions, block diagrams, and technical documentation.
• Support requirements traceability, change management, and compliance with FDA Design Controls.
• Participate in system integration, risk management, design verification, and validation activities.
• Prepare and execute system-level test plans, including functional and performance testing, and analyse test results.
• Collaborate with cross-functional engineering teams, global stakeholders, PMOs, and external partners.




• Support risk analysis activities, including FMEA, DFMEA, hazard analysis, and fault tree analysis.
• Maintain design documentation, risk management files, and quality and compliance records.
• Contribute to continuous improvement initiatives and engineering process optimisation. Required Skills and Experience
• 4–6 years of experience in Systems Engineering R&D;, preferably in the medical device industry.
• Hands-on experience in system design, systems integration, and product development or sustaining engineering.
• Knowledge of systems engineering methodologies, requirements management, and system modelling.
• Familiarity with FDA Design Controls, 21 CFR Part 820, ISO 14971, and IEC 60601.
• Understanding of software lifecycle requirements, including IEC 62304.
• Exposure to Model-Based Systems Engineering (MBSE) and tools such as IBM DOORS or Jama Connect.
• Knowledge of system-level risk management, verification, and validation.
• Ability to work in Agile/Scrum and stage-gate development environments.
• Solid analytical, documentation, communication, and cross-functional collaboration skills.
• Preferred: Experience in endoscopy or other complex medical devices, hardware/circuit board development, and global R&D; project environments.

📌 System Engineer (Hyderabad)
🏢 SolidPro - HelixA
📍 Hyderabad