Lead System Engineer

About the Role
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.
Strong problem-solving and ownership mindset.
Preferred Background
Candidates from:
Medical Devices
MedTech Startups
Healthcare Electronics
IoT Products
Wearables
Robotics
Embedded Product Companies
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

Work arrangement
No