Senior Director, R&D and Manufacturing Solutions

TransMedics; Andover (MA); On-site; USD 230,000 - 330,000; Full time

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.

Education

Bachelor's degree in Information Technology, Computer Science, Engineering, Manufacturing, Supply Chain, Life Sciences, or a related field

Job description

POSITION SUMMARY

As a key contributing leader of the Digital and IT leadership team, the Senior Director, R&D and Manufacturing Solutions will define and implement the digital solutions that enable product development, manufacturing, quality, supply chain, and product lifecycle management. This leader will own the technology portfolio spanning ERP, MES, QMS, supply chain, and R&D systems with the following mandates:
Accelerate manufacturing 4.0 through AI, automation, connected operations, and data-driven decision-making; and drive the digital and connected capabilities of medical devices through secure IoT technologies.
Partner with business leaders to enable remote connectivity and management of our organ devices, working in partnership with the Clinical and Logistics Solution teams.
Drive modernization and improvements of our core manufacturing platforms such as ERP, MES and other mission critical systems globally.

RESPONSIBILITIES

R&D, Manufacturing and Quality Solution Strategy

• 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 tightly with R&D, manufacturing, quality, regulatory, supply chain, finance, clinical, data, infrastructure, enterprise architecture, and cybersecurity teams to deliver integrated and compliant capabilities.

R&D, Manufacturing and Quality Solutions Execution

• 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 seamless information flow and master-data integrity 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 and build deploy ML, AI and automation solutions into the application stack to improve yield, throughput, reliability, inspection, forecasting, and root-cause analysis.
• Drive the digital capabilities of 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.

MANAGEMENT RESPONSIBILITIES

• Build and maintain a high performing team responsible to execute the scope of responsibility.
• Manage and maintain partner relationships across technology and service providers that support your function. Hold our partners accountable in getting the most value from our relationships.
• Develop organizational capabilities, succession plans and targeted talent development strategies to maintain a high performing team.

PHYSICAL ATTRIBUTES

None identified

MINIMUM QUALIFICATIONS

• 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 that are used by both internal and external users at scale.
• 10+ years of experience architecting and implementation 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 portfolio.