Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Cloud & Digital Platform Architect will lead and contribute to the development of Digital, Cloud and connected software systems for medical devices. This role involves implementing complex features, reviewing design decisions, and mentoring team members while ensuring software quality and regulatory compliance. The ideal candidate brings strong Digital and Cloud software expertise, practical experience in regulated development, and collaborative skills to drive project execution.

Responsibilities

Design and implement cloud-native data platform (Data Lake / Lakehouse) for clinical, device, and operational data.
Build scalable pipelines for:
- Device telemetry (MQTT → ingestion → storage)
- Clinical data (FHIR / HL7 / EMR integrations)
Enable analytics and reporting using:
- Amazon Redshift
- Athena / Glue / S3-based Data Lake
Ensure HIPAA-compliant data storage, encryption, and governance
- Support real-time + batch analytics use cases
Design and enable AI/ML use cases, including:
- Predictive alerts (device failures, patient risk)
- Clinical insights (treatment optimization)
Build and operationalize MLOps pipelines.
Leverage AI-assisted tools (e.g. Codex, Claude, GitHub Copilot) to:
- Accelerate development
- Improve code quality
- Automate documentation and testing

Collaborate with data science teams for model deployment
Lead technical design discussions and guide implementation of scalable, maintainable code.
Support architecture development in coordination with SMEs.
Ensure traceability, testing, and documentation meet regulatory requirements (IEC 62304, ISO 14971, FDA Class B/C).
Contribute to AAMI-TIR45 compliant Agile processes including sprint planning, reviews, retrospectives, and documentation.
Apply secure coding practices and support implementation of cybersecurity features for connected systems.
Participate in risk analysis, root cause investigation, and design reviews.

Required Skills & Abilities

Solid grounding in software architecture including AWS well architected framework.
Cloud, Data & AI Expertise
- Deep expertise in AWS including:
  - IoT Core, Lambda, API Gateway, Cognito
  - RDS / Aurora PostgreSQL
  - S3, Glue, Athena, Redshift (Data Warehouse)
  - EventBridge, SNS, SQS, Kinesis
- Experience designing:
  - Data Lakes / Lakehouse architectures
  - Real-time + batch data pipelines
- Familiarity with:
  - MLOps and ML platforms (e.g., SageMaker)
  - AI-assisted development tools (Codex, Claude, Copilot)
- Strong knowledge of:
  - Event-driven architecture
  - Multi-tenant SaaS systems
  - Observability framewor

Experience with:
- Prompt engineering for code generation
- AI-assisted debugging and test generation
Ability to define guardrails for regulated environments.
Device identity + certificate lifecycle (PKI, mTLS)
Threat modeling for connected devices
Compliance with:
- FDA Cybersecurity Guidance
- ISO 27001 / HITRUST (if applicable)

Education & Experience

Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
10+ years of experience in embedded software development, including regulated product development.
Strong understanding of IEC 62304 and ISO 14971, with experience generating supporting documentation.

Travel

The willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

Physical Requirements

Sustained periods of time standing and sitting in a laboratory
Sitting at a desk utilizing a computer
Some lifting of<25 pounds

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.

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