Location: Westminster, CO (Hybrid, 2-3 days WFH)

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.

Key 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

Required Qualifications
• 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

Salary Range
• $125,000 - 135,000
• The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job-related knowledge, qualifications, skills, education, training, and experience