TransMedics, Inc.

.Enterprise Architect (Contract)

TransMedics, Inc.  •  Andover, MA (Onsite)  •  3 days ago
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Job Description

TransMedics is seeking an Enterprise Architect (Contractor) to serve as the principal technical authority shaping the architecture, integration, and long-term evolution of the company's enterprise technology ecosystem. As TransMedics accelerates its digital transformation journey, this role will provide the strategic and technical foundation across three interconnected domains: Enterprise Applications (Oracle Fusion ERP, Critical Manufacturing MES, EQMS, Workday HCM, LIMS, and standard corporate platforms), Infrastructure & Platform (AWS cloud foundations, DevOps toolchains, and shared services), and Data Architecture (data governance, integration patterns, and analytics enablement).

This is a senior individual contributor role that operates at the intersection of technology strategy, systems integration, and business alignment. The ideal candidate will bring hands-on architectural experience in regulated environments, preferably within the medical device or life sciences industry, and will be adept at translating complex technical landscapes into clear roadmaps that support scalable global growth, operational excellence, and regulatory compliance.

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.
  • Hands-on 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.
  • Proven ability to develop and communicate architectural roadmaps and strategies to senior stakeholders.
  • Excellent communication, documentation, and facilitation skills.

PREFERRED QUALIFICATIONS

  • Experience in regulated environments (medical device, biotech, or pharmaceutical) with working knowledge of FDA 21 CFR Part 11, SOX, ISO 13485, and/or GDPR.
  • 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.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insurance Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

TransMedics, Inc.

About TransMedics, Inc.

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, and clinical care.

With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.

www.TransMedics.com

Industry
Manufacturing & Production
Company Size
501-1,000 employees
Headquarters
Andover, MA
Year Founded
1998
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