16 Oct
|
SolidPro - HelixA
|
Hyderabad
16 Oct
SolidPro - HelixA
Hyderabad
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 wit
📌 System Engineer (Hyderabad)
🏢 SolidPro - HelixA
📍 Hyderabad