Department: System Engineering – Research & Development

Location:
Hyderabad, Telangana, India

Experience:
6–10 Years Employment Type: Full-time

About the Role
We are looking for an experienced Senior System Engineer to lead the design, integration and validation of complex medical device systems. The role involves developing system architectures, defining system requirements, managing system-level risks and ensuring seamless integration across mechanical, electrical, hardware, software and embedded systems. The ideal candidate will bring strong systems engineering expertise, hands-on R&D; experience and the ability to collaborate with cross-functional teams and external partners to deliver high-quality, reliable and regulatory-compliant medical device solutions.

Key Responsibilities
System Engineering & Product Development
• Lead the design and development of system architectures for medical devices, ensuring effective integration of mechanical, electrical, software and embedded subsystems.
• Define system requirements and specifications based on user needs, regulatory requirements and design inputs.
• Develop and maintain system models and technical documentation, including block diagrams, interface definitions and design specifications.
• Drive system design and implementation from concept through production.
• Conduct detailed design reviews with internal engineering teams and external vendor partners.
• Manage the complete systems engineering lifecycle, including requirements definition, architecture, risk management, design, verification, validation and release.
• Drive hardware, software and firmware integration.
• Manage system requirements, traceability and engineering change management.
• Apply systems engineering techniques such as requirements management,



system modelling, simulation and validation.
• Provide technical guidance and mentorship to junior engineers and vendor partners.
• Develop and validate system-level test protocols. Project & Stakeholder Management
• Support project risk management by identifying, documenting and tracking technical risks.
• Prepare technical reports covering project progress, design validation, testing outcomes and engineering challenges.
• Coordinate with PMO teams, global stakeholders and external partners to ensure technical alignment and timely project delivery.
• Support vendor partner performance tracking, SLA monitoring and demand planning. Regulatory & Compliance
• Support product development in alignment with FDA, CE, ISO and other applicable regulatory and industry standards.
• Collaborate with external teams and certification bodies on applicable safety requirements.
• Apply risk management methodologies, including hazard analysis, Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA).
• Maintain technical documentation in accordance with Valuable Manufacturing Practices (GMP) and quality system requirements. Continuous Improvement
• Identify opportunities to improve product performance, reduce costs and enhance ease of use.
• Stay updated on emerging technologies and advancements in systems engineering.




• Contribute to continuous improvement in engineering processes and product development activities.
• Mentor junior engineers and promote engineering best practices. Required Qualifications
• Bachelor's degree or higher qualification in Biomedical Engineering or Systems Engineering.
• Master's degree in Biomedical or Systems Engineering is an added advantage.
• 6–10 years of experience in System Engineering R&D; within the medical device domain.
• Experience handling both technical and managerial responsibilities.
• Strong technical background in system design and circuit board development.
• Experience in medical device product development is preferred.
• Proven experience collaborating with PMOs, global teams and external vendor partners. Technical Skills & Expertise
• Strong knowledge of systems engineering methodologies, system modelling and requirements management.
• Experience in system architecture, system integration and requirements traceability.
• Understanding of medical device product lifecycle management and FDA Design Controls.
• Knowledge of regulatory standards, including 21 CFR Part 820, ISO 14971 and IEC 60601.
• Experience with Model-Based Systems Engineering (MBSE) tools and methodologies.
• Familiarity with Agile Scrum and Stage-Gate development environments.
• Understanding of software lifecycle management, including IEC 62304.
• Experience with requirements management tools such as DOORS and JAMA.
• Knowledge of risk analysis, hazard analysis and DFMEA processes.
• Ability to develop requirements specifications, risk management files and compliance documentation.
• Strong stakeholder management, communication and technical reporting skills.
• Work Location
• Hyderabad, Telangana, India

📌 Senior System Engineer (Hyderabad)
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