Senior Firmware Engineer, Medical Devices

Job Description

Job Description

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.

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

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age, genetic information, or pregnancy.

Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.

Compliance Notice: Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.