Senior Director, R&D and Manufacturing Solutions

TransMedics, Inc.•Andover, MA

About The Position

As a key contributing leader of the Digital and IT leadership team, the Senior Director, R&D and Manufacturing Solutions defines and implements digital solutions that enable product development, manufacturing, quality, supply chain, and product lifecycle management. The role owns a technology portfolio spanning ERP, MES, QMS, supply chain, and R&D systems. The position accelerates Manufacturing 4.0 through AI, automation, connected operations, and data-driven decision-making, and advances the secure IoT capabilities of medical devices. It partners with business leaders and Clinical and Logistics Solution teams to enable remote connectivity and management of organ devices, while modernizing core manufacturing platforms and other mission-critical systems globally. This visible leader builds trusted relationships across R&D, engineering, manufacturing, operations, supply chain, and quality. The role combines hands-on contribution with coaching, translating product and operational needs into scalable digital solutions that speed innovation, strengthen compliance, improve manufacturing performance, and enhance connected medical-device capabilities. It also builds and develops a high-performing team and manages technology and service-provider relationships.

Requirements

Bachelor's degree in Information Technology, Computer Science, Engineering, Manufacturing, Supply Chain, Life Sciences, or a related field.
15+ years of progressive experience delivering digital solutions across R&D, manufacturing, quality, supply chain, product lifecycle, or enterprise applications, including significant leadership responsibility.
12+ years of experience building and leading cloud-native engineering application teams.
10+ years of experience building solutions used at scale by both internal and external users.
10+ years of experience architecting and implementing digital applications that leverage ML and AI models.
10+ years of experience architecting and building applications across native mobile and web frameworks.
Demonstrated ownership of complex ERP, MES, QMS, supply chain, PLM, laboratory, engineering, or related regulated-technology portfolios.
Strong knowledge of medical-device product development, design controls, manufacturing, quality systems, validation, data integrity, traceability, and lifecycle-management processes.
Experience defining and implementing Manufacturing 4.0 capabilities using industrial IoT, connected equipment, automation, robotics, machine vision, real-time data, advanced analytics, AI, or digital twins.
Experience delivering secure IoT and connected-product capabilities for medical devices or other regulated products, including telemetry, remote monitoring, device integration, and lifecycle management.
Excellent communication, leadership, talent-development, stakeholder-management, vendor-management, and organizational-change skills.

Nice To Haves

Experience in medical devices, life sciences, pharmaceuticals, biotechnology, or another highly regulated manufacturing environment.
Experience with global manufacturing operations and regulatory expectations, including FDA Quality System requirements, ISO 13485, GxP, 21 CFR Part 11, and applicable international standards.
Experience with cloud-connected medical devices, edge computing, device cybersecurity, over-the-air software or configuration management, and product telemetry.
Strong experience with Agile product management, architecture governance, computer-system validation, operational excellence, Lean manufacturing, and validated software delivery.

Responsibilities

Define and execute a multi-year product and capability roadmap across R&D, product development, manufacturing, quality, supply chain, and product lifecycle management.
Develop a deep understanding of engineering, laboratory, design-control, production, quality, maintenance, planning, procurement, warehousing, and distribution workflows.
Partner with R&D, manufacturing, quality, regulatory, supply chain, finance, clinical, data, infrastructure, enterprise architecture, and cybersecurity teams to deliver integrated and compliant capabilities.
Own the lifecycle, architecture, integration, reliability, adoption, support, enhancement, and retirement of ERP, MES, QMS, supply chain, product lifecycle, laboratory, engineering, and other R&D-supporting technologies.
Ensure information flows seamlessly and master data remains integral across product design, bills of material, recipes and routings, planning, procurement, production, quality, inventory, distribution, service, and financial processes.
Enable compliant digital design controls, requirements management, documentation, change control, training, deviations, CAPA, complaints, audits, supplier quality, and electronic records.
Advance Manufacturing 4.0 through connected equipment, electronic work instructions and records, automated material and data flows, robotics, machine vision, predictive maintenance, process monitoring, digital twins, and real-time performance management.
Partner with teams to build and deploy ML, AI, and automation solutions into the application stack to improve yield, throughput, reliability, inspection, forecasting, and root-cause analysis.
Drive digital capabilities for TransMedics medical devices using secure IoT architecture, device connectivity, telemetry, remote monitoring, diagnostics, software and configuration management, and integration with enterprise and product platforms.
Ensure solutions and connected-device capabilities meet applicable quality, validation, cybersecurity, privacy, safety, regulatory, data-integrity, and electronic-record requirements.
Build and maintain a high-performing team responsible for executing the function’s scope.
Manage and maintain relationships with technology and service-provider partners, holding them accountable for delivering value.
Develop organizational capabilities, succession plans, and targeted talent-development strategies.