Program Manager, New Product Development

Program ManagerWe 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.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 developmentEnsure 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 assignedMinimum 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.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 MADentalVisionHealthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insuranceEmployee Stock Purchase PlanTransMedics 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.