Job description

Role Summary Drive NOTIS™ from research prototype to Product 1.0. You will harden our cerebral-ischemia detection algorithm, deploy it as a secure cloud micro-service, and expose a REST / gRPC API that streams EEG data from OR devices and returns real-time ischemia-risk scores + change alerts. You’ll own the full SaMD engineering stack—model packaging, test automation, DevOps, and post-market telemetry—working closely with clinical, AI, and regulatory teams. Key Responsibilities • Algorithm “Close-Out” – refactor research code into production-grade Python (PyTorch) modules; optimize inference, reproducibility, and version control. • API & Device Integration – design/implement secure REST / gRPC endpoints; ingest real-time EEG streams via TCP/HL7/FHIR; return risk scores and structured event messages (<10 ms latency target). • Testing & Verification – develop unit, and integration, lead verification/validation per IEC 62304, ISO 13485, and FDA Software as a Medical Device guidance. • Security & Compliance – embed HIPAA, ISO 27001, OWASP, and FDA cybersecurity pre-market guidance into architecture; generate design history and DHF artefacts for De Novo submission. • Cross-Functional Collaboration – partner with neurologists, ML scientists, and quality/regulatory leads to translate clinical requirements into engineering specs and release notes. Minimum Qualifications • B.S./M.S. in CS, EE, Biomedical Eng or related. • 5+ yrs building production ML or signal-processing services. • Expertise in Python, containerization (Docker/K8s), cloud architecture (AWS/Azure/GCP). • Proven experience designing REST/gRPC APIs and real-time data pipelines. • Working knowledge of software quality systems (IEC 62304 or ISO 13485) and automated testing frameworks (pytest, GitHub Actions, or similar). Preferred Extras • Experience with physiological signals (EEG/ECG/EMG). • Familiarity with FDA SaMD, 21 CFR 820, ISO 14971 risk management. • Infrastructure-as-Code (Terraform/CDK), event streaming (Kafka), or edge-device SDKs. • Prior role in start-up or Class II/III medical device product launch. Why NOTIS™ Join a mission-driven team turning breakthrough AI into a first-of-its-kind brain-monitoring platform that can save lives and minds in every operating room. Equal Opportunity Employer – we celebrate diversity and are committed to an inclusive environment for all employees.

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