Lead Firmware Engineer

22 hours ago

Thāne, Maharashtra, India Digital Health Solutions Full time
About Us:   Digital Health Solutions (DHS) is a U.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. 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. 

Architect and oversee development of embedded systems that use 32-bit microcontrollers (STM32, NXP, TI) and application processors (ARM Cortex-A, i.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. 

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. 

Produce and maintain high-quality documentation: system architecture specifications, design rationales, test protocols, and risk analyses. 

10+ years of hands-on experience in embedded systems development, preferably in regulated industries such as medical devices, aerospace, automotive, or industrial safety. 

~ Proficient in C and C++ for real-time, safety-critical, and low-level systems. 

~ Deep expertise in embedded Linux development, including Yocto, Buildroot, kernel customization, and driver integration. 

~ Strong experience with RTOS (e.g., Solid understanding of ARM Cortex-M/A architectures, embedded security, and peripheral interfaces. 

~ Familiar with relevant standards and regulatory frameworks, including IEC 62304, ISO 14971, and FDA software validation. 

~ Experience with wireless protocols (BLE, Wi-Fi, LoRa) and embedded cybersecurity practices. 

~

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