Program Manager, New Product Development

Job Description: Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships POSITION SUMMARY We are seeking a highly motivated and experienced Program Manager to lead cross-functional teams in the development and commercialization of innovative medical device products, including capital equipment, disposable components, and software-enabled systems. This role requires strong leadership, technical acumen, and program management expertise to ensure that product development efforts align with company objectives, regulatory requirements, and market expectations. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead end-to-end program execution for complex medical device systems that integrate capital equipment, disposables, and embedded software components. Develop and manage comprehensive program plans, including scope, schedules, budgets, and resource allocation, to deliver new product development projects on time and within budget. Lead the creation and management of comprehensive program schedules, including detailed Gantt charts and Work Breakdown Structures (WBS); analyze critical paths, key workstreams, and interdependencies to proactively manage timeline risks. Coordinate with cross-functional teams including R&D, Quality, Regulatory, Clinical, Operations, and Commercial to achieve program goals. Manage dependencies and integration points between hardware, disposable, and software development streams, ensuring synchronized timelines and risk mitigation strategies. Oversee design control activities for all device components, ensuring robust documentation, traceability, and regulatory readiness. Manage vendor relationships for third-party components, including software platforms, contract manufacturers, and testing partners. Serve as the primary point of contact for program communications, both internally and externally, including with senior leadership and strategic partners. Coach and mentor team members on all aspects of project management, including planning, execution, risk mitigation, stakeholder communication, and delivery best practices to ensure consistent project success and team development Ensure compliance with relevant regulatory standards (e.g., FDA 21 CFR 820, ISO 13485, EU MDR). Facilitate phase gate reviews and ensure documentation meets quality and regulatory standards. Track and report on key program metrics, escalate issues appropriately, and drive resolutions. Identify and implement process improvements to enhance program delivery and team efficiency. Lead continuous improvement initiatives to optimize program management processes. All other duties as assigned MINIMUM QUALIFICATIONS: Bachelor’s degree in Engineering, Life Sciences, or a related technical field; 8+ years of experience in program or project management within the medical device, biotech, or FDA/ISO regulated industry. PREFERRED SKILLS: Master’s degree or MBA preferred. Experience with Class II or Class III medical devices. Demonstrated experience managing full product lifecycle projects, including design control and regulatory submission processes. Proven track record leading cross-functional teams and delivering FDA-regulated products. Strong knowledge of quality systems and regulatory requirements (FDA, ISO, etc.). PMP or similar certification. Excellent organizational, leadership, and communication skills. Ability to manage multiple priorities and thrive in a fast-paced, dynamic environment. Proficiency with project management tools (e.g., MS Project, Smartsheet, JIRA, etc.).. Background in systems engineering or integration of hardware/software platforms. Familiarity with clinical trial planning and execution. Working knowledge of risk management (ISO 14971), usability engineering, and design verification/validation. 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 $147,200.00 – $183,600.00, 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: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.