We are seeking a Lead Systems Engineer – R&D; (Embedded Systems) with strong experience in embedded hardware, firmware, and product development. The candidate will be responsible for owning end-to-end product development, from concept and prototyping to validation and manufacturing.
The role requires a hands-on engineer who can work independently, solve technical challenges, and contribute to building innovative medical devices.
Key Responsibilities
- Own end-to-end R&D; product development lifecycle.
- Design and develop embedded systems for medical devices.
- Develop embedded firmware using Embedded C/C .
- Work on PCB/PCBA design, hardware bring-up, and debugging.
- Handle system integration, testing, and validation activities.
- Prepare technical documentation and support compliance activities.
- Work with vendors and manufacturing partners for product development.
- Collaborate with cross-functional teams including Mechanical, Software, Quality, and Manufacturing.
Required Skills
- Embedded Systems Development
- Embedded C/C
- Embedded Firmware Development
- Embedded Hardware Design
- PCB/PCBA Design & Review
- Microcontrollers (STM32, ARM Cortex, ESP32, PIC, etc.)
- Hardware Debugging & System Integration
- Product Development Lifecycle
- Medical Device / MedTech experience
- IEC 60601 / IEC 61000 knowledge
- ISO 14971 Risk Management
- DFMEA
- Verification & Validation (V&V;)
- Manufacturing Transfer Experience
Candidate Requirements
- 3–5 years of experience in Embedded Systems/Product Development.
- Must have R&D; experience in building physical products.
- Medical Device / MedTech experience is mandatory.
- Experience owning products/projects from prototype to production.
- Robust problem-solving and ownership mindset.
Additional Requirements
- Candidates must have direct Medical Device R&D; experience.
- 2–3 years of Medical Device experience is preferred.
- Experience developing regulated medical devices from prototype to production is required.
- Candidate must have worked in Medical Device R&D;/product development.
- Mandatory – candidate should have owned products from concept → prototype → validation → manufacturing.
- Embedded Hardware Firmware System Integration (Mandatory)
- Preferred: Embedded C/C experience
- Candidate should independently develop and debug firmware
- Preferred: PCB/PCBA design and hardware bring-up experience
- Should have experience with microcontrollers: STM32 / ARM Cortex / ESP32 / PIC or similar
- Mandatory working knowledge of medical device compliance standards: IEC 60601, IEC 61000, ISO 14971
- Preferred: DFMEA / Risk Management experience
- Preferred: product manufacturing transfer experience
- All above backgrounds are acceptable
- Only candidates with healthcare electronics background can be considered
- Independent technical owner who can drive complete R&D; projects
- All above are acceptable
- Strictly onsite 6 days
📌 Lead System Engineer( medical devices ) (Delhi)
🏢 GoodSpace AI
📍 Delhi
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