Job Description:

The Vice President, Manufacturing is a key member of our Operations leadership team joining TransMedics at a critical inflection point in our growth. As we prepare to launch our next-generation product platform and expand our manufacturing footprint, this leader will have the opportunity to shape the future of manufacturing at TransMedics.

This leader will have a dual mandate: lead the continued transformation, performance, and scale of our existing manufacturing operation in Andover, MA while simultaneously building the manufacturing model for our next generation of products at our new Somerville, MA facility. This includes establishing the operating systems, technology, automation, organization, and culture required to build a world-class manufacturing operation from the ground up.

Beyond our immediate expansion, this leader will establish a scalable Manufacturing Excellence blueprint that can serve as the foundation for future sites and potential global manufacturing expansion as TransMedics continues to grow.

RESPONSIBILITIES

Manufacturing Leadership & Operational Excellence

• Lead our existing Andover manufacturing operation and establish a high-performing Manufacturing Leadership Team accountable for Safety, Quality, Delivery, and Cost (SQDC).
• Drive the continued transformation of our existing manufacturing operations, establishing the processes, systems, capabilities, and operating discipline required to support significant growth.
• Establish and embed a world-class manufacturing operating system incorporating standardized processes and controls, visual performance management, tiered daily management, strong front-line leadership, quality-first execution, and structured problem solving.
• Drive sustained improvements in yield, throughput, cycle time, productivity, inventory flow and accuracy, operational stability, and cost.
• Champion Lean, Six Sigma, and continuous improvement methodologies to reduce variability, eliminate waste and bottlenecks, and improve operational performance.
• Leverage MES, operational data, and performance metrics to strengthen visibility, data integrity, accountability, and decision-making throughout manufacturing.
• Translate our business plans, demand forecasts, and product roadmaps into manufacturing capacity, workforce, capital, technology, and footprint requirements.
• Serve as our senior manufacturing leader, advising executive leadership on capacity, operational risk, investment priorities, and key manufacturing tradeoffs.

Next-Generation Manufacturing & Scale

• Lead the manufacturing strategy, design, build, validation, and ramp of our new Somerville, MA manufacturing facility to support TransMedics' next-generation product platform.
• Build our next-generation manufacturing model from the ground up, incorporating world-class principles across production flow, automation, advanced manufacturing technology, digital capabilities, quality, scalability, and operational excellence.
• Develop and execute a manufacturing technology and automation roadmap that evolves our production environment toward increasingly automated and robotic-assisted manufacturing where appropriate.
• Lead manufacturing requirements across facility and production layout, equipment and automation, workforce and organizational design, capital planning, process transfer and validation, regulatory readiness, and ramp to volume.
• Serve as the senior manufacturing owner for new product introduction and transfer into production, partnering closely with Advanced Operations, R&D, Engineering, Quality, Regulatory, and Supply Chain to ensure process maturity, manufacturability, training, validation, quality, and readiness for scale.
• Ensure lessons learned and best practices from our existing operations inform the new manufacturing environment while taking the opportunity to fundamentally rethink processes and capabilities for our next generation of products.
• Establish the Somerville manufacturing model as a scalable platform that can be replicated across future TransMedics manufacturing sites, including potential global expansion.
• Develop our longer-term manufacturing footprint and capacity strategy, including future site requirements, make/buy decisions, automation, equipment strategy, and other capabilities required to support our continued growth.

Quality & Regulatory Excellence

• Ensure our manufacturing operations comply with applicable FDA regulations, ISO 13485, Quality Management Systems, and other global regulatory requirements.
• Champion a quality-first culture in which product quality, patient impact, risk management, and regulatory compliance are embedded in our manufacturing operations and decision-making.
• Partner closely with Quality and Regulatory leadership on audits, inspections, validation, corrective actions, process capability, and ongoing quality-system improvements.
• Ensure our manufacturing processes, documentation, training, systems, and controls remain capable and compliant as production volumes and organizational complexity increase.

Organization & Leadership

• Build, develop, and retain a high-performing manufacturing organization and leadership team capable of supporting our current operations and future growth.
• Establish the organizational structure, leadership capabilities, accountability, decision rights, performance expectations, and management cadence required to operate effectively at increasing scale.
• Develop manufacturing leaders at all levels and build strong succession, talent development, and front-line leadership capabilities.
• Lead our manufacturing organization through significant growth and transformation, creating alignment around new processes, technologies, expectations, and ways of working.
• Foster a culture of continuous improvement, accountability, urgency, and disciplined execution while developing our people to grow alongside the business.
• Model a leadership style that balances urgency and high standards with collaboration and respect.

REQUIREMENTS

• Bachelor's degree in Engineering, Manufacturing, Operations, Business, or a related discipline required; Master's degree or MBA preferred.
• Minimum 15+ years of progressive manufacturing and operations leadership experience, including significant leadership responsibility within a complex manufacturing environment.
• Strong experience within medical device, life sciences, or another highly regulated manufacturing environment; direct medical device experience strongly preferred.
• Demonstrated success transforming and scaling manufacturing operations while delivering sustained improvements in safety, quality, delivery, cost, throughput, and productivity.
• Demonstrated experience building or significantly expanding manufacturing capabilities, including the development, launch, validation, and ramp of a new manufacturing facility or major production operation.
• Experience establishing manufacturing operating systems incorporating Lean, continuous improvement, tiered daily management, standard work, visual management, and structured problem solving.
• Experience with manufacturing automation, advanced manufacturing technologies, MES, and the transition from manual toward increasingly automated production environments.
• Strong understanding of new product introduction, design transfer, process validation, manufacturing readiness, and production scale-up.
• Working knowledge of FDA regulations, ISO 13485, Quality Management Systems, and applicable requirements for regulated manufacturing.
• Strong strategic and financial acumen, including manufacturing capacity and footprint planning, capital investment, operating budgets, productivity, and cost management.
• Demonstrated ability to build, develop, and lead high-performing manufacturing organizations and leadership teams through significant growth and change.
• Exceptional leadership, communication, and change-management skills with the ability to operate effectively from the executive level to the manufacturing floor.

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.

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.