Program Manager, New Product Development

TransMedics, Inc.•Andover, MA

19h

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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