Senior Firmware Engineer, Medical Devices

Were ALTEN Technology USA an engineering company helping clients bring groundbreaking ideas to lifefrom advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3000 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 Group57000 engineers in 30 countrieswe deliver across the entire product development cycle from consulting to full project outsourcing.

When you join ALTEN Technology USA youll collaborate on some of the worlds 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 clients 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
$125000 - 135000
The actual salary offered is dependent on various factors including but not limited to location the candidates 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.

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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.