Senior Director, R&D and Manufacturing Solutions

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 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 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

PREFERRED QUALIFICATIONS  

• 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
  

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, clinical care and outcomes.  

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. 

Maximize your potential at TransMedics, Inc. 
www.TransMedics.com  

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.