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.
As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.
Every Organ Wasted is a Life Not Saved.
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 committed to equitable and transparent compensation. The expected base salary range for this role is $209,100.00 – $327,100.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.
Employee Benefit:
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.
Employee Benefit:
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.
Skills Required
- Bachelor's degree in Engineering, Manufacturing, Operations, Business, or a related discipline
- Master's degree or MBA
- 15+ years of progressive manufacturing and operations leadership experience
- Significant leadership responsibility within a complex manufacturing environment
- Experience in medical device, life sciences, or another highly regulated manufacturing environment
- Direct medical device manufacturing experience
- Success transforming and scaling manufacturing operations with improvements in safety, quality, delivery, cost, throughput, and productivity
- Experience building or significantly expanding manufacturing capabilities, including launching, validating, and ramping a new facility or major production operation
- Experience with Lean, continuous improvement, tiered daily management, standard work, visual management, and structured problem solving
- Experience with manufacturing automation, advanced manufacturing technologies, MES, and transitioning manual production toward automation
- 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 regulated manufacturing requirements
- Strategic and financial acumen in capacity and footprint planning, capital investment, operating budgets, productivity, and cost management
- Ability to build, develop, and lead high-performing manufacturing organizations through growth and change
- Exceptional leadership, communication, and change-management skills
What We Do
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, and clinical care. With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.
