Firmware Development Lead

About Us :

Digital Health Solutions (DHS) is a U.S.-based ISO 13485–certified MedTech engineering and regulatory consulting firm with a strong global presence. In India, we operate through our affiliate, Biovantage Technology Solutions Pvt. Ltd., based in Mumbai.

We are seeking a skilled and hands-on Embedded Firmware Engineer to lead the design and development of embedded hardware and firmware systems, spanning microcontroller and microprocessor-based solutions. The ideal candidate will have at least 10 years of experience in embedded systems development, particularly in medical devices or other highly regulated industries. This role will be instrumental in designing high-reliability embedded architectures, ensuring compliance with medical device standards (IEC 62304, ISO 13485, FDA 21 CFR Part 820), and guiding development teams through full product lifecycles.

Responsibilities :

• Architect and oversee development of embedded systems that use 32-bit microcontrollers (STM32, NXP, TI) and application processors (ARM Cortex-A, i.MX, etc.).
• Drive the complete product life-cycle—concept, requirements capture, architecture, design, implementation, verification, release, and long-term maintenance.
• Collaborate with hardware, software, quality, and regulatory teams to translate product requirements and constraints into robust system architectures.
• Lead firmware development in C and C++ for bare-metal, RTOS, and embedded-Linux targets, including board support packages, bootloaders, and secure update mechanisms.
• Define board-level hardware architecture—power, sensing, and communication subsystems (UART, SPI, I²C, CAN, USB, BLE, Wi-Fi, cellular)—in partnership with hardware engineers.
• Perform system bring-up, low-level debugging, and integration of BSPs, device drivers, and middleware.
• Ensure compliance with FDA regulations, ISO 13485, IEC 62304, and cybersecurity guidance (AAMI TIR57, FDA Premarket Cybersecurity).
• Lead risk-management activities, including hazard analysis, FMEA, and verification / validation planning and execution.
• Evaluate and recommend embedded platforms, SoCs, and communication protocols that best meet technical, cost, and schedule objectives.
• Conduct design and code reviews, establish best practices, and mentor junior engineers.
• Produce and maintain high-quality documentation : system architecture specifications, design rationales, test protocols, and risk analyses.

Qualifications :