Job Title

Role OverviewWe are seeking a Senior Digital Architect to lead the strategic design, governance, and evolution of enterprise-wide digital ecosystems across the MedTech landscape. This role drives architectural vision for connected medical devices, regulated digital health platforms, cloud and data infrastructure, cybersecurity frameworks, and compliant software solutions supporting global markets.The ideal candidate is a recognized technical leader with deep expertise in healthcare technology standards, cloud-native platform engineering, cybersecurity, regulated software development, and digital transformation within FDA- and MDR-governed environments.Key Responsibilities1. Enterprise & Digital Ecosystem ArchitectureDefine and own the strategic digital architecture roadmap spanning devices, mobile/ web solutions, cloud platforms, and data systemsDevelop and evolve enterprise reference architectures for IoT-enabled medical devices, digital therapeutics, and SaMD solutionsChair architecture governance forums, establish architectural guardrails, and ensure alignment with long-term business and clinical strategiesDrive architectural modernization, cloud transformation, and digital capability scaling across the organization2. MedTech Compliance & Regulatory Architecture LeadershipEnsure architecture is compliant with global healthcare regulatory frameworks (FDA, MDR, HIPAA, GDPR, etc.)Lead system designs aligned with IEC 62304, ISO 13485, ISO 14971, and risk-based engineering practicesProvide architectural leadership for software safety classification, technical file documentation, and risk management processesPartner with Quality, Regulatory, and Clinical teams to ensure end-to-end compliance across product lifecycle3. Cloud, DevSecOps & Platform EngineeringArchitect large-scale, secure, high-availability platforms on AWS, Azure, or GCPDefine enterprise-level DevSecOps, CI/CD, and cloud governance frameworksLead strategy for containerization, orchestration (Docker, Kubernetes), and cloud-native microservicesDrive adoption of API-first, domain-driven design (DDD), and event-driven architectures.4. Data, AI Enablement & Healthcare InteroperabilityDesign and evolve enterprise healthcare data platforms supporting HL7, FHIR, DICOM, and EHR integrationArchitect secure data pipelines, analytics frameworks, and AI/ML enablement for regulated environmentsDefine and enforce master data governance, data privacy, and cybersecurity controlsEnsure interoperability with hospital systems, national networks, and third-party clinical platforms5. Cybersecurity, Privacy & Risk ArchitectureEstablish and govern zero-trust architecture, identity strategies, and secure connectivity for medical devicesLead secure software development lifecycle (SSDLC) adoption across engineering teamsPerform advanced threat modeling, security risk assessments, and define mitigation strategiesEnsure continuous compliance with patient data protection standards across global geographies.6. Organizational Leadership & Strategic CollaborationMentor and guide solution architects, principal engineers, and cross-functional technical leadersPartner with Product, Clinical, Commercial, Quality, and Regulatory leadership to shape digital portfolio strategyEvaluate emerging technologies, strategic vendors, and platforms aligned with long-term digital strategySupport technical due diligence for partnerships, acquisitions, and global expansion initiatives.Required QualificationsBachelor’s or master’s degree in computer science, Engineering, or a related field18+ years of experience in enterprise or solution architecture, with 5+ years in MedTech or regulated healthcareDemonstrated mastery of medical software lifecycle standards & regulated developmentProven track record architecting cloud-native, secure, scalable healthcare platformsExperience with IoT connectivity, embedded-to-cloud integration, and secure device ecosystemsStrong understanding of FDA 21 CFR Part 820, EU MDR, SaMD, and global regulatory frameworksDeep expertise in cybersecurity for medical devices and digital health applicationsPreferred QualificationsExperience with Software as a Medical Device (SaMD)Experience integrating with major EHR vendors (e.g., Epic, Cerner)Knowledge of AI/ML applications in medical devicesCertification in cloud architecture (AWS/Azure/GCP)TOGAF or equivalent enterprise architecture certificationKey CompetenciesStrategic thinking and systems design mindsetStrong stakeholder communication skillsRisk-based decision makingDeep understanding of regulated product developmentAbility to balance innovation with compliance