Cloud & Digital Platform Architect

Job Description Company & Job OverviewDiality 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.ResponsibilitiesDesign and implement cloud-native data platform (Data Lake / Lakehouse) for clinical, device, and operational data.Build scalable pipelines for:Device telemetry (MQTT &rarr; ingestion &rarr; storage)Clinical data (FHIR / HL7 / EMR integrations)Enable analytics and reporting using:Amazon RedshiftAthena / Glue / S3-based Data LakeEnsure HIPAA-compliant data storage, encryption, and governanceSupport real-time + batch analytics use casesDesign 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 developmentImprove code qualityAutomate documentation and testingCollaborate with data science teams for model deploymentLead 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 & AbilitiesSolid grounding in software architecture including AWS well architected framework.Cloud, Data & AI ExpertiseDeep expertise in AWS including:IoT Core, Lambda, API Gateway, CognitoRDS / Aurora PostgreSQLS3, Glue, Athena, Redshift (Data Warehouse)EventBridge, SNS, SQS, KinesisExperience designing:Data Lakes / Lakehouse architecturesReal-time + batch data pipelinesFamiliarity with:MLOps and ML platforms (e.g., SageMaker)AI-assisted development tools (Codex, Claude, Copilot)Strong knowledge of:Event-driven architectureMulti-tenant SaaS systemsObservability frameworExperience with:Prompt engineering for code generationAI-assisted debugging and test generationAbility to define guardrails for regulated environments.Device identity + certificate lifecycle (PKI, mTLS)Threat modeling for connected devicesCompliance with:FDA Cybersecurity GuidanceISO 27001 / HITRUST (if applicable)Education & ExperienceBachelor'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.TravelThe willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.Physical RequirementsSustained periods of time standing and sitting in a laboratorySitting at a desk utilizing a computerSome lifting of<25 poundsThe 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.