Staff Software Engineer

A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, IL and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded out of a Northwestern University Biotechnology lab, with a specific focus on our most vulnerable patients - pregnant persons and babies - where we believe wireless monitoring has the potential to do the most good worldwide. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

Sibel Health is hiring a Staff Software Engineer to pioneer AI-enabled feature engineering - a model where a single engineer owns an entire feature pipeline end to end, using AI coding agents to do the work that previously required a coordinated team. You will own the delivery of complete product features from backend to mobile - from the server and cloud services that ingest, process, and expose physiological data to the mobile applications that clinicians use at the bedside. You will also own the system architecture for the features you build, the system- and software-level verification and validation (V&V) that proves they work, and the lifecycle documentation that governs your work. Critically, you will own how those features actually land in a hospital. Our software does not run in a lab - it runs on hospital networks, integrates with clinical systems, and must survive the operational realities of real deployments. You should have direct experience deploying software into hospital or comparable enterprise environments and integrating with the systems already running there.

WHAT YOU WILL BE WORKING ON:

System Architecture

• Own the architecture for the features and subsystems you deliver: component decomposition, interface contracts, data models, and deployment topology.
• Define and document the external system interfaces your features expose - to sensor gateways, hospital systems, clinical applications, and third-party integrators.
• Make deployment-aware architectural decisions: what must run on-premises for latency, reliability, or data residency reasons, and what belongs in the cloud.
• Evaluate architectural trade-offs explicitly and document the reasoning so future engineers (and AI agents) inherit the context, not just the code.
• Contribute to platform-level architecture discussions with software platform owners and systems engineering - your feature-level decisions must stay consistent with system-level intent.

Backend Platform Development

• Design and implement backend services for data ingestion, real-time processing, storage, analytics, and clinical integration - deployed to both cloud (AWS) and on-premises hospital servers. Our current stack is Python, but strong backend engineers in any language can ramp quickly.
• Own the data pipeline from sensor gateway to clinical system: MQTT ingestion, stream processing (Kafka), storage, alert evaluation engine, and FHIR R4 API exposure.
• Build and maintain FHIR-compliant APIs and interoperability interfaces for hospital system integration (Epic, Cerner, Capsule/Sickbay).
• Design and operate infrastructure across AWS (Lambda, DynamoDB, Cognito, API Gateway) and on-premises server environments deployed within hospital networks. Understand the constraints of both: cloud elasticity on one side, hospital network segmentation, firewall rules, and local data residency on the other.
• Ensure backend services meet security, compliance, and scalability requirements across both deployment targets: HIPAA, SOC 2, and FDA cybersecurity guidance (Section 524B).

Mobile Application Development

• Build and maintain mobile applications (Flutter) on Android and iOS for real-time patient monitoring, clinical alerting, and sensor management.
• Own BLE communication from the mobile side: connection management, GATT operations, reconnection strategies, and background processing within platform constraints (CoreBluetooth/Android BLE).
• Implement real-time data visualization, alarm presentation (IEC 60601-1-8 compliant), and clinical workflow features.
• Ensure mobile performance: battery optimization, memory management, and responsive UI under real-time data streaming loads.
• Coordinate with firmware engineering on BLE protocol contracts, data formats, and connection parameter tuning - ensuring the mobile layer correctly consumes what the sensor produces.

Deployment & Clinical Integration

• Plan and execute software deployments into hospital environments, including on-premises server installation, configuration, and site-specific validation.
• Implement and troubleshoot clinical system integrations: FHIR R4, HL7v2 messaging, ADT feeds, and vendor middleware.
• Produce deployment documentation, network requirement specifications, and security documentation that hospital IT teams can actually act on.
• Support go-live activities and post-deployment issue resolution—including remote diagnosis in restricted-access environments.
• Design observability into the system: logging, metrics, and health signals that make on-site behavior visible without on-site access.

Verification, Validation & Lifecycle Documentation

• Own the verification and validation lifecycle for your features end to end, per the Sibel Software Development Plan and applicable QMS procedures.
• Produce and maintain: SRS, SDS, Verification Plan, Test Cases, Verification Report, and bidirectional traceability matrices (requirements ↔ design ↔ tests ↔ results).
• Perform risk-based verification: ensure test coverage is proportional to software safety classification and risk control measures identified in ISO 14971 risk management.
• Manage SOUP/OTS software assessment for third-party libraries and frameworks (Flutter packages, Python libraries, AWS SDKs).
• Participate in software change control: assess impact of changes on existing verification evidence, re-verify as needed, and maintain configuration management records.
• Support regulatory submissions (510(k), De Novo) by ensuring all software lifecycle documentation is complete, consistent, and audit-ready - and by flagging procedural gaps that would weaken a submission.

Cross-Functional Leadership

• Serve as the single technical point of contact for features that span backend and mobile.
• Partner with systems, firmware, software and the V&V team.

ABOUT YOU:

• 8 - 12 years of software engineering experience with demonstrated depth in both backend and mobile development.
• System architecture experience : ownership of architecture of non-trivial systems - defining component boundaries, interface contracts, and deployment topology.
• Strong systems thinking : the ability to reason about how a change in the backend affects mobile behavior, and how mobile-side requirements constrain backend API design. Comfort working at the system-interface level, not just within a single layer.
• Backend experience : production experience building backend services - API design, data pipelines, event-driven architectures. Experience deploying to cloud and/or on-premises server environments.
• Mobile development : Flutter, Kotlin, or Swift, including real-time data handling and platform-specific performance optimization.
• Hospital or enterprise deployment : hands-on experience deploying software into hospital, clinical, or comparably constrained enterprise environments.
• Clinical or enterprise system integration : experience integrating with external systems of record - EHR platforms, clinical middleware, or equivalent enterprise systems - using standards-based interfaces (FHIR, HL7v2) or vendor APIs.
• Standards literacy : the ability to distinguish technical standards that shape implementation (RFC 9110, IEEE 11073, IEC 60601-1-8, BLE GATT) from operational standards that shape process (IEC 62304, ISO 13485, ISO 14971) and to trace how a requirement derives from the standard behind it.
• Regulated environment documentation : experience producing lifecycle or compliance documentation (IEC 62304, ISO 26262, DO-178C, or equivalent). Medical device experience is ideal but not required - experience in any safety-critical domain translates directly.
• System and software-level V&V : writing test plans, executing verification testing at both the system-interface and software-unit level, and producing audit-ready evidence that traces to requirements.
• AI coding agents : hands-on experience with Claude, Cursor, Copilot, or similar - including maintaining agent instruction files, crafting effective prompts, and optimizing workflows.
• Specification & documentation skills : the ability to define cross-layer interface contracts, acceptance criteria, and architectural decisions with precision.

YOU MAY THRIVE IN THIS ROLE IF:

• Experience in medical devices, digital health, healthcare, or any regulated product development environment.
• BLE protocol integration from the mobile/gateway side: GATT services, connection parameter negotiation, and reliability in clinical RF environments.
• Infrastructure-as-code (Terraform, CDK, CloudFormation, Ansible) and deployment automation across cloud and on-premises environments.
• Real-time data systems: stream processing (Kafka, MQTT), time-series databases, and event-driven architectures.
• Building and maintaining AI agent instruction files, prompt libraries, or context engineering systems for development teams.

Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.