System Engineer medical devices
Tata Elxsi · Posted Oct 12
Design and technology services, product engineering, systems integration, and digital transformation solutions
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About the role
Tata Elxsi works with leading medical device OEMs and technology companies on market research and human factor engineering, hardware and software engineering, verification & validation, and regulatory standards & compliance, and its Medical Device and Healthcare practice is ISO 13485 certified. This role leads end-to-end system design of respiratory therapy devices, spanning hardware, firmware, and software integration, requirements definition, and traceability. The engineer also drives safety risk management and regulatory compliance across the product lifecycle.
What you will do
- Lead the end-to-end system design of respiratory therapy devices, including hardware, firmware, and software integration.
- Define system-level requirements and specifications in collaboration with cross-functional teams.
- Evaluate the technical, regulatory, and safety implications of engineering and design change requests to ensure system integrity and compliance throughout the product lifecycle.
- Identify and define Critical to Safety (CTS) and Critical to Quality (CTQ) parameters during design and development.
- Support verification and validation (V&V) activities across system and subsystem levels.
- Maintain and update traceability matrices for system requirements, risks, and testing.
- Ensure adequate traceability from design inputs to verification outputs and risk mitigations.
- Apply strong understanding of safety risk management, including: DFMEA, Product risk analysis, Risk mitigations
- Ensure compliance with ISO 14971 and other relevant risk management standards.
- Demonstrated knowledge of global regulatory frameworks including: FDA 21 CFR Part 820.30, ISO 13485, IEC 60601 series, ISO 14971
Skills used in this role
What the employer is looking for
- System Engineering for medical devices (12+ years, 8+ years in medical device industry)
- Requirements Engineering & Traceability Management
- System Architecture & Solution Definition
- Cross-Functional Design Integration (HW, SW, Mechanical, Clinical)
- Risk Management & Systems Safety (ISO 14971)
- Knowhow of medical device standards and regulations
Benefits and support
- Compensation and benefits are detailed in the job posting
About Tata Elxsi
Tata Elxsi is a global provider of design-led technology services, specializing in product engineering, systems integration, and digital transformation. Operating across sectors like transportation, healthcare, and media, the company combines design thinking with advanced technologies such as AI, cloud, and IoT to help enterprises build connected, intelligent products.
- Industry
- Design Services
- Company size
- 11500+ employees
- Founded
- 1989
- Location
- Bengaluru, India
- Funding stage
- Public Company
Funding
Public Company · $0 raised
Leadership
Manoj Raghavan
CEO & Managing Director
Nalin Rana
Chief Financial Officer
Recent coverage
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