Software Architect

• Define and maintain the architecture strategy, technical standards, design principles, and reference architectures for backend services, shared platform capabilities, APIs, integrations, and connected-product software systems.
• Establish clear architectural boundaries between regulated medical device functionality, supporting system functionality, and non-medical-device functionality through documented interfaces, service boundaries, risk isolation, data ownership, access controls, and deployment strategies.
• Define reusable backend and platform patterns that support mobile applications, web applications, connected devices, customer-facing workflows, internal tools, and future shared service needs.
• Serve as the senior technical authority for backend and platform architecture decisions, with responsibility for data flows, identity, integrations, telemetry, observability, and operational reliability.
• Lead architecture reviews, technical trade-off discussions, design assessments, risk reviews, and decision-making for new products, major features, platform changes, and modernization efforts.
• Design and govern secure, scalable, resilient, maintainable, and observable cloud-based service architectures that support connected medical device products and related digital services.
• Guide cybersecurity architecture for cloud and platform services, including secure design patterns, threat modeling, access control, data protection, monitoring, vulnerability management, and secure update support.
• Create and maintain review-ready architecture documentation, including system diagrams, interface definitions, data flows, architecture decision records, deployment models, and design content that supports traceability.
• Ensure architecture artifacts support design controls, Design History File inputs, FDA 510(k) submission support, cybersecurity documentation, software change assessments, risk management, verification planning, and controlled release activities.
• Collaborate cross-functionally with internal teams and external development partners to build alignment, improve architecture governance, and strengthen internal ownership of critical technical decisions.

• Bachelor’s degree in Computer Science, Computer Engineering, or a related technical discipline.
• 10+ years of professional software engineering experience designing and delivering commercial software products, including backend services, APIs, integrations, cloud-based systems, or shared platform capabilities.
• 5+ years in senior technical leadership roles such as Software Architect, Principal Engineer, Staff Engineer, Technical Lead, or an equivalent role.
• Medical device software development experience, including requirements traceability, design controls, risk management, verification evidence, change control, release documentation, and formal design review.
• Strong background defining architecture for backend services, service boundaries, data flows, APIs, identity, integration patterns, observability, deployment models, and operational reliability.
• Demonstrated ability to create clear, review-ready architecture documentation, including system diagrams, interface specifications, data flow diagrams, architecture decision records, deployment models, technology inventories, and design content that supports traceability.
• Working knowledge of secure software architecture practices, including secure design patterns, threat modeling, access control, data protection, vulnerability management, and risk-based architecture decision-making., * Architecture background for digital health products, connected products, cloud-based regulated software systems, or software platforms that support regulated product workflows.
• Contributions to FDA 510(k) software documentation, cybersecurity documentation, software architecture packages, software change assessments, or regulated release activities.
• Familiarity with IEC 62304, ISO 14971, medical device cybersecurity guidance, SBOM/SOUP concepts, design controls, and Design History File expectations.
• Background with Azure cloud services, cloud-native architecture, SaaS platforms, platform engineering, DevOps, CI/CD, infrastructure as code, observability, or operational reliability practices.
• Azure Solutions Architect, Azure Developer, Azure Security, CISSP, CSSLP, or similar architecture, cloud, platform, or cybersecurity certification.

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.

Below is the starting salary or hourly range for this position, although offers may differ based on the candidate’s location, job-specific knowledge, skills and experience. US Pay Range $100,500-$165,000 USD