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.
As a visible leader in the organization, you will build trusted relationships across R&D, engineering, manufacturing, operations, supply chain and quality teams. You will be a player and a coach, translating product and operational needs into scalable digital solutions that speed innovation, strengthen compliance, improve manufacturing performance, and enhance the connected capabilities of our medical devices.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
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…