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Enterprise Architect

Perfict Global, Inc.

  • Concord, CA
  • 30+ days ago
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    Skills

    • Amazon Web Services (AWS)unmatched
    • Application Programming Interface (API)unmatched
    • Architectural Designunmatched
    • Architectural Servicesunmatched
    • Best Practicesunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Business Intelligenceunmatched
    • Business Strategyunmatched
    • Cloud Applicationsunmatched
    • Cloud Architectureunmatched
    • Cloud Computingunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Computer Scienceunmatched
    • Computer Securityunmatched
    • Cross-Functionalunmatched
    • Cryptographyunmatched
    • Data Analysisunmatched
    • Data Modelingunmatched
    • Data Qualityunmatched
    • Database Extract Transform and Load (ETL)unmatched
    • Disaster Recoveryunmatched
    • Documentationunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Enterprise Applicationsunmatched
    • Enterprise Architectureunmatched
    • Enterprise Protectionunmatched
    • Enterprise Service Bus (ESB)unmatched
    • FDA (Food and Drug Administration)unmatched
    • FDA Requirementsunmatched
    • Financeunmatched
    • High Availabilityunmatched
    • ISO (International Organization for Standardization)unmatched
    • Identity Data Managementunmatched
    • Information Technology & Information Systemsunmatched
    • Internal Auditunmatched
    • Internet of Thingsunmatched
    • Laboratory Information Management System (LIMS)unmatched
    • Machine Toolunmatched
    • Make-Versus-Buy Analysisunmatched
    • Manufacturingunmatched
    • Manufacturing Execution Systems (MES)unmatched
    • Master Data Management (MDM)unmatched
    • Medical Equipmentunmatched
    • Mentoringunmatched
    • Middlewareunmatched
    • Multiplatform/Cross-Platformunmatched
    • Operational Auditunmatched
    • Operations Security (OPSEC)unmatched
    • Oracleunmatched
    • Oracle ERPunmatched
    • Oracle Fusion Middlewareunmatched
    • Records Managementunmatched
    • Regulationsunmatched
    • Reporting Dashboardsunmatched
    • Requirements Managementunmatched
    • Riskunmatched
    • Risk Managementunmatched
    • Sarbanes-Oxley Act (SOX)unmatched
    • Supplier Relationship Management (SRM)unmatched
    • Supply Chainunmatched
    • System Integration (SI)unmatched
    • System Validationunmatched
    • Systems Administration/Managementunmatched
    • Technical Leadershipunmatched
    • Technical Strategyunmatched
    • Technology Analysisunmatched
    • Total Cost of Ownershipunmatched
    • Traceabilityunmatched
    • Vendor/Supplier Relationsunmatched

    Description

    Job Title : 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.

    Numbers & Facts

    LocationConcord, CA

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