Tata Elxsi is among the world’s leading providers of design and technology services across industries, including automotive, broadcast, communications, healthcare, and transportation. Tata Elxsi works with leading OEMs and suppliers in the automotive and transportation industries for R&D, design, and product engineering services from architecture to launch and beyond.

We are looking for experienced Systems Engineers/Systems Leads to join our MEBU/HLSBU team.

Roles & Responsibilities:

• Lead system design for respiratory therapy devices, covering hardware, firmware, and software integration.
• Define system-level requirements and collaborate with cross-functional engineering teams.
• Evaluate technical, regulatory, and safety impact of design changes across the product lifecycle.
• Identify and define CTS (Critical to Safety) and CTQ (Critical to Quality) parameters.
• Support V&V activities at system and subsystem levels.
• Maintain traceability matrices for requirements, risks, and test coverage.
• Ensure complete traceability from design inputs to verification outputs and risk mitigations.
• Apply strong safety risk management practices, including DFMEA, risk analysis, and mitigation strategies.
• Ensure compliance with ISO 14971 and other applicable standards.
• Work with global regulatory frameworks: FDA 21 CFR 820.30, ISO 13485, IEC 60601 series, ISO 14971.
• Maintain DHF documentation, traceability matrices, and risk files.
• Use requirement management tools like IBM DOORS and lifecycle platforms like Windchill.
• Collaborate with mechanical, electrical, software, quality, and regulatory teams.
• Drive and participate in design reviews, risk assessments, and Phase Gate Reviews.

Preferred Education & Skills:

• M.Tech / B.E. / B.Tech in Biomedical, Electrical, Mechanical, Systems Engineering, or related fields.
• 5–10 years total experience, with 3–5 years in medical device development.
• Experience with ventilators, CPAP, BiPAP, or similar life-support systems (highly preferred).
• Solid understanding of systems engineering principles and product lifecycle.
• Exposure to design controls and regulatory frameworks (FDA, ISO 13485).
• Knowledge of ISO 14971 risk management processes.
• Hands-on testing, debugging, and documentation experience.
• Familiarity with DOORS and Windchill is an added advantage.
• Strong analytical, problem-solving, written, and verbal communication skills.