Enterprise Architect

Enterprise Architect

Location: Somerville, MA

Long Term Contract

Responsibilities

Enterprise Architecture Strategy & Governance

• Define and maintain the enterprise architecture framework, standards, and principles across application, infrastructure, and data domains.
• Develop and own the enterprise technology roadmap, aligning it with TransMedics' business strategy, digital transformation objectives, and regulatory obligations.
• Establish and chair an Architecture Review process to evaluate new technology investments, integration patterns, and platform changes against established standards.
• Assess the current-state architecture and identify gaps, technical debt, and opportunities for consolidation, modernization, or optimization.
• Provide architectural oversight and guidance to project teams, business partners, and technical leads across all enterprise systems.
• Partner with IT leadership to ensure technology decisions are made with full awareness of architectural implications and total cost of ownership.

Enterprise Applications Architecture

• Serve as the architectural authority for TransMedics' enterprise application portfolio including Oracle Fusion ERP (Finance, SCM, Manufacturing), Critical Manufacturing MES, EQMS, Workday HCM, LIMS, and other corporate platforms.
• Define integration architecture and data exchange patterns between enterprise applications, ensuring alignment, traceability, and minimal redundancy across the application landscape.
• Guide Business Partners and Technical Leads on system design decisions, ensuring configurations and customizations adhere to architectural best practices and do not introduce unnecessary complexity or technical debt.
• Lead architectural design for new module implementations, system upgrades, and cross-functional platform initiatives.
• Evaluate build vs. buy vs. configure decisions and provide recommendations based on strategic fit, regulatory impact, and total cost of ownership.

Infrastructure & Platform Architecture

• Own the cloud infrastructure architecture strategy on AWS, defining standards for compute, networking, storage, security, and resilience across hosted enterprise applications and platform services.
• Define cloud landing zone design, account structure, and AWS service patterns that support enterprise workload requirements including SOX, FDA 21 CFR Part 11, GDPR, and ISO 13485 compliance.
• Design shared platform services including identity and access management (IAM), secrets management, monitoring, logging, and alerting in alignment with enterprise security policies.
• Collaborate with IT Operations and Security teams to ensure infrastructure architecture supports high availability, disaster recovery, and business continuity requirements.
• Evaluate and recommend managed AWS services to support enterprise system hosting and integration needs.

Data Architecture & Governance

• Define and drive the enterprise data architecture strategy, including data models, master data management (MDM), data flows, and integration patterns across Oracle Fusion, MES, EQMS, Workday, LIMS, and other systems.
• Establish data governance frameworks covering data ownership, data quality, classification, lineage, and lifecycle management across the enterprise application landscape.
• Design scalable data integration patterns (APIs, event-driven, ETL/ELT) to enable real-time and batch data flows between systems.
• Partner with Finance, Supply Chain, Manufacturing, HR, and Quality stakeholders to define analytical data requirements and enable reporting, dashboards, and business intelligence capabilities.
• Ensure data architecture supports regulatory traceability requirements including FDA 21 CFR Part 11, SOX audit trails, ISO 13485 records management, and GDPR data residency and privacy requirements.
• Evaluate and recommend data platform technologies (e.g., AWS data services, data lakehouse, MDM tooling) to support enterprise analytics and operational reporting needs.

Compliance, Security & Risk

• Ensure all architectural decisions and designs comply with applicable regulatory requirements including FDA, SOX, GDPR, ISO 13485, and 21 CFR Part 11.
• Embed security-by-design principles into architecture patterns, including zero-trust networking, least-privilege access, data encryption, and audit logging.
• Partner with Compliance, Internal Audit, and Quality teams during system validations, audits, and assessments to demonstrate architectural controls.
• Maintain an architectural risk register and communicate technology risks and mitigation strategies to IT leadership and relevant stakeholders.

Stakeholder Engagement & Technical Leadership

• Act as a trusted advisor to IT leadership, Business Partners, and Technical Leads, bridging the gap between business strategy and technical execution.
• Communicate complex architectural concepts clearly to both technical and non-technical audiences including senior business leaders.
• Lead architectural discovery workshops, design sessions, and technology evaluations with cross-functional stakeholders.
• Manage relationships with key technology vendors and partners — Oracle, AWS, Critical Manufacturing, Workday, ensuring alignment with TransMedics' architectural direction.
• Mentor and provide architectural guidance to Business Partners and Technical Leads across the enterprise systems team.

Management Responsibilities

• No direct reports (This position will not have management responsibilities).

Physical Attributes

• None (Standard office environment).

Minimum Qualifications

• Bachelor's degree in Information Systems, Computer Science, Engineering, or related field.
• 8–12+ years of progressive IT experience with at least 3–5 years in an enterprise or solution architecture role.
• Demonstrated experience architecting solutions across enterprise application, cloud infrastructure, and data domains within a complex, multi-system environment.
• Experience with Oracle Fusion (ERP, SCM, or Finance modules) and/or other major ERP platforms in a design or architecture capacity.
• Strong working knowledge of AWS cloud services and cloud architecture patterns.
• Experience designing enterprise integration architectures using APIs, event-driven patterns, ESB/middleware, and ETL/ELT approaches.
• Solid understanding of data architecture principles including MDM, data governance, data modeling, and analytics platform design.
• Experience in regulated environments (medical device, biotech, or pharmaceutical) with working knowledge of FDA 21 CFR Part 11, SOX, ISO 13485, and/or GDPR.
• Proven ability to develop and communicate architectural roadmaps and strategies to senior stakeholders.
• Excellent communication, documentation, and facilitation skills.

Preferred Qualifications

• Experience with Manufacturing Execution Systems (preferably Critical Manufacturing), EQMS, or LIMS platforms in an architecture or integration capacity.
• Familiarity with Workday HCM integration architecture and platform extensibility.
• Experience with AWS data platform services such as Redshift or equivalent data lakehouse solutions.
• Exposure to Industry 4.0 concepts, Industrial IoT, and smart manufacturing architectures.
• Experience supporting digital transformation programs in growth-stage or mid-size life sciences companies.