Software Firmware Engineer - Medical Device

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.