Director, Digital R&D & Smart Manufacturing Solutions

TransMedics, Inc.

Andover (MA)

On-site

USD 230,000 - 330,000

Full time

3 days ago

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Job summary

TransMedics, Inc. is seeking a Senior Director, R&D and Manufacturing Solutions to define and implement digital solutions across product development, manufacturing, quality, supply chain, and product lifecycle management.

You will own ERP, MES, QMS, and connected-device capabilities, driving AI/automation, secure IoT, and data-driven decision-making for global operations. The role requires extensive leadership and a track record building scalable, cloud-native applications powered by ML/AI, with

Qualifications

Bachelor's degree required in IT, CS, engineering, manufacturing, supply chain, life sciences, or related field.
15+ years delivering digital solutions across R&D, manufacturing, quality, supply chain, PLM or enterprise apps with leadership.
12+ years building cloud-native engineering teams.
10+ years building solutions used by internal/external users at scale.
10+ years architecting digital apps leveraging ML/AI models.
10+ years building apps across native mobile and web frameworks.
Demonstrated ownership of complex ERP, MES, QMS, supply chain, PLM, lab or regulated-technology portfolio.

Responsibilities

Define and execute a multi-year product and capability roadmap across R&D, manufacturing, quality, supply chain, and PLM.
Understand engineering, laboratory, design-control, production, quality, maintenance, planning, procurement, warehousing, and distribution workflows.
Partner with diverse teams to deliver integrated and compliant capabilities.
Own lifecycle, architecture, integration, reliability, adoption, support, enhancement and retirement of ERP, MES, QMS, supply chain, PLM, lab, and other R&D-supporting tech.
Ensure master-data integrity across product design, BOMs, recipes and routings, planning, procurement, production, quality, inventory, distribution, service, and finance.
Enable compliant design controls, requirements management, documentation, change control, training, deviations, CAPA, complaints, audits, supplier quality, and e-records.
Advance Manufacturing 4.0 with connected equipment, WIs, data flows, robotics, ML/AI-powered insights.
Drive digital capabilities of TransMedics medical devices via secure IoT, telemetry, remote monitoring, diagnostics, software/config management, and integrations.
Ensure solutions meet quality, validation, cybersecurity, privacy, safety, regulatory, data integrity, and e-record requirements.
Build and maintain high-performing team, manage partners, and develop talent.