Medical Device Embedded Software Engineer

Embedded Software Engineer Mid-level (L4 equivalent) 2-5 years

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The job description

Tech stack. C/C++, IEC 62304, ISO 13485, ARM Cortex-M, FreeRTOS, BLE, risk management (ISO 14971), design controls

About the role

You will join a medical device company building a connected wearable that monitors patients continuously and alerts clinicians to deterioration. The embedded team works under IEC 62304 and FDA design controls, where software items are classified by risk and every anomaly is a potential patient-safety issue. This role matters because the device sits between a patient and a missed alarm: your firmware has to be right, provably right, and right every time the patient moves, sweats, or sleeps. You will partner with quality, clinical, and systems engineers from concept through verification and into the clinical study.

What you will achieve

Ship Class B/C software items under IEC 62304 for a wearable monitor through design verification and into a clinical study, with all verification records audit-ready
Drive anomaly and risk-control implementation so that every software-related hazard in the risk file has a verified firmware mitigation traced to a test result
Reduce false-alarm rates by improving signal-quality detection in firmware, cutting nuisance alerts by 30% as measured in clinical data from the pilot study
Build a BLE data pipeline to the companion app that maintains 99.5% packet delivery during 24-hour ambulatory use, including reconnection after signal loss
Own the software verification protocol for your items, executing and documenting unit, integration, and system tests to a standard that passes internal audit on first review

What you will bring

Must-haves

2-5 years in medical device embedded software (or another IEC 62304/regulated environment) with design-control experience
Strong C/C++ on ARM Cortex-M with RTOS experience in a safety-conscious codebase where every change is reviewed
Working knowledge of IEC 62304 software lifecycle processes and software safety classification of items and units
Familiarity with ISO 14971 risk management as it applies to software hazards and risk controls
Experience writing verification protocols and test reports that withstand internal and external audit
Hands-on BLE development for a shipped connected device, including coexistence and reconnection behavior
Discipline with configuration management, change control, and documentation in a regulated quality system

Nice-to-haves

Experience with FDA submissions such as 510(k) involving software documentation
Knowledge of cybersecurity for medical devices: threat modeling, SBOM, and patchability planning
Signal processing experience for physiological signals such as ECG, PPG, or accelerometry