Role Overview
We 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 Responsibilities
1. Enterprise & Digital Ecosystem Architecture
- Define and own the strategic digital architecture roadmap spanning devices, mobile/ web solutions, cloud platforms, and data systems
- Develop and evolve enterprise reference architectures for IoT-enabled medical devices, digital therapeutics, and SaMD solutions
- Chair architecture governance forums, establish architectural guardrails, and ensure alignment with long-term business and clinical strategies
- Drive architectural modernization, cloud transformation, and digital capability scaling across the organization
2. MedTech Compliance & Regulatory Architecture Leadership
- Ensure 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 practices
- Provide architectural leadership for software safety classification, technical file documentation, and risk management processes
- Partner with Quality, Regulatory, and Clinical teams to ensure end-to-end compliance across product lifecycle
3. Cloud, DevSecOps & Platform Engineering
- Architect large-scale, secure, high-availability platforms on AWS, Azure, or GCP
- Define enterprise-level DevSecOps, CI/CD, and cloud governance frameworks
- Lead strategy for containerization, orchestration (Docker, Kubernetes), and cloud-native microservices
- Drive adoption of API-first, domain-driven design (DDD), and event-driven architectures.
4. Data, AI Enablement & Healthcare Interoperability
- Design and evolve enterprise healthcare data platforms supporting HL7, FHIR, DICOM, and EHR integration
- Architect secure data pipelines, analytics frameworks, and AI/ML enablement for regulated environments
- Define and enforce master data governance, data privacy, and cybersecurity controls
- Ensure interoperability with hospital systems, national networks, and third-party clinical platforms
5. Cybersecurity, Privacy & Risk Architecture
- Establish and govern zero-trust architecture, identity strategies, and secure connectivity for medical devices
- Lead secure software development lifecycle (SSDLC) adoption across engineering teams
- Perform advanced threat modeling, security risk assessments, and define mitigation strategies
Ensure continuous compliance with patient data protection standards across global geographies.
6. Organizational Leadership & Strategic Collaboration
- Mentor and guide solution architects, principal engineers, and cross-functional technical leaders
- Partner with Product, Clinical, Commercial, Quality, and Regulatory leadership to shape digital portfolio strategy
- Evaluate emerging technologies, strategic vendors, and platforms aligned with long-term digital strategy
- Support technical due diligence for partnerships, acquisitions, and global expansion initiatives.
Required Qualifications
- Bachelor's or master's degree in computer science, Engineering, or a related field
- 18+ years of experience in enterprise or solution architecture, with 5+ years in MedTech or regulated healthcare
- Demonstrated mastery of medical software lifecycle standards & regulated development
- Proven track record architecting cloud-native, secure, scalable healthcare platforms
- Experience with IoT connectivity, embedded-to-cloud integration, and secure device ecosystems
- Strong understanding of FDA 21 CFR Part 820, EU MDR, SaMD, and global regulatory frameworks
- Deep expertise in cybersecurity for medical devices and digital health applications
Preferred Qualifications
- Experience with Software as a Medical Device (SaMD)
- Experience integrating with major EHR vendors (e.g., Epic, Cerner)
- Knowledge of AI/ML applications in medical devices
- Certification in cloud architecture (AWS/Azure/GCP)
- TOGAF or equivalent enterprise architecture certification
Key Competencies
- Strategic thinking and systems design mindset
- Strong stakeholder communication skills
- Risk-based decision making
- Deep understanding of regulated product development
- Ability to balance innovation with compliance
