What are the responsibilities and job description for the Software Firmware Engineer - Medical Device position at Blue Arbor Technologies, Inc.?
Software / Firmware Engineer
1099 Independent Contractor · Hybrid – Ann Arbor, MI · Competitive Rate
Blue Arbor Technologies is developing a Class III implantable neurostimulation device to restore meaningful function for individuals living with limb differences. We build to exacting standards because our patients depend on it. We are seeking a rigorous, self-driven Software / Firmware Engineer to join our small engineering team at a pivotal stage of product development.
WHY THIS ROLE MATTERS
You will own software and firmware development end-to-end — from requirements through verification — for a system that will ultimately be implanted in a human being. That responsibility is not taken lightly here, and we expect you to feel the same way.
WHAT YOU WILL DO
– Design, develop, and validate embedded firmware (C/C ) and software for SaMD/SiMD medical device systems, including interfaces with prosthetic device ecosystems.
– Implement software in conformance with IEC 62304 and the company's design control procedures.
– Author and execute V&V test plans, software risk assessments, hazard analyses, and anomaly reports.
– Elicit, document, and trace software requirements from clinicians, end users, and cross-functional partners into the Design History File.
– Support FDA regulatory submissions (510(k), De Novo, or PMA) and respond to agency queries.
– Contribute to cybersecurity risk documentation in accordance with FDA guidance for connected devices.
– Partner daily with hardware engineers, quality, regulatory affairs, and clinical stakeholders in a small, agile team.
WHAT YOU BRING
– Master's or PhD in Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Science, or a closely related field.
– 3 – 5 years of firmware and/or software development experience in a regulated medical device environment.
– Demonstrated IEC 62304-compliant SaMD/SiMD development experience.
– Hands-on embedded firmware skills and familiarity with protocols such as BLE, SPI, UART, or I2C.
– Working knowledge of ISO 14971, FDA 21 CFR Part 820, and FDA SaMD guidance.
– Prior FDA submission experience (510(k), De Novo, or PMA) is strongly preferred.
– Startup experience and comfort with a high degree of ownership and ambiguity are a meaningful plus.
ENGAGEMENT DETAILS
– 1099 independent contractor engagement — competitive hourly or project rate commensurate with experience.
– Part-time, hybrid arrangement; 2 – 3 days per week on-site in Ann Arbor, MI.
– Occasional travel to partner facilities, clinical sites, or regulatory agencies may be required.
If you are motivated by the opportunity to shape a life-changing product from the ground up — and you hold yourself to the standard that the patient deserves — we want to hear from you.