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