Senior Firmware Engineer, Medical Devices

ALTEN Technology USA•Westminster, CO

6d•$125,000 - $135,000•Hybrid

About The Position

We are seeking a Senior Firmware Engineer to support our client, a well-funded medical device company developing a handheld, wireless, battery-powered point-of-care diagnostic instrument for trauma and critical care use, including ambulance and air medical transport. This role offers the opportunity to contribute directly to a device platform moving toward FDA 510(k) clearance.

Requirements

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

Nice To Haves

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

Responsibilities

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