Senior Firmware Engineer, Medical Devices

• Design, implement, and test firmware for a battery-powered, wireless handheld diagnostic instrument, including BLE communication, sensor/test-strip interfacing, and power management for field use

• Develop firmware robust to real-world environmental stress (vibration, temperature/humidity variation) consistent with ambulance and air-transport use

• Own firmware architecture broadly across the device platform, given the size of the client's engineering team

• Develop firmware in compliance with IEC 62304 (medical device software lifecycle) and support design controls under 21 CFR Part 820

• Write and execute unit, integration, and verification test protocols; support formal V&V and risk analysis (FMEA) activities, with deliverables tied to an active FDA 510(k) submission timeline

• Debug hardware/firmware issues using oscilloscopes, logic analyzers, and JTAG/SWD tools

• Participate in design reviews, root cause investigations, and CAPA activities as needed

• Mentor junior engineers and contribute to firmware coding standards

• Collaborate with regulatory/quality teams to maintain design history file (DHF) documentation

• B.S. in Electrical Engineering, Computer Engineering, or related field

• 6+ years of embedded/firmware development experience, with 2+ years in a regulated industry (medical device, aerospace, or automotive)

• Strong proficiency in C/C++ for embedded systems

• Experience with RTOS-based development (FreeRTOS, ThreadX, or similar)

• Hands-on experience with ARM Cortex-M or similar microcontroller platforms

• Strong BLE and low-power embedded design experience

• Familiarity with additional communication protocols: I2C, SPI, UART, USB

• Experience with version control (Git) and static analysis tools

• Comfort operating in a lean engineering environment with close leadership access

Preferred Qualifications

• Direct experience with IEC 62304, ISO 13485, or IEC 60601 in a prior role

• Exposure to Class II/III medical device development and FDA 510(k) submissions

• Experience with test automation frameworks for embedded verification

We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life-from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group-57,000+ engineers in 30 countries-we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you'll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.