Senior Firmware Engineer, Medical Devices

Location

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

• 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.

• Direct experience with IEC 62304, ISO 13485, or IEC 60601 in a prior role.
• Exposure to ClassII/III medical device development and FDA
  510(k) submissions.
• Experience with test automation frameworks for embedded verification.

• $,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.

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.