TransMedics

TransMedics

Program Manager, New Product Development

Andover, MA

Sponsorship not specified$147k-$184kDetected 7 days ago
Product ManagementProject ManagementJiraStakeholder ManagementRecruitingEmbedded SystemsSystems EngineeringPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationCollaboration

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37Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

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About the role

  • 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

  • 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.
  • 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.
  • Track and report on key program metrics, escalate issues appropriately, and drive resolutions.
  • 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.
  • Identify and implement process improvements to enhance program delivery and team efficiency.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related technical field;

Skills

  • Master's degree or MBA preferred.
  • Experience with Class II or Class III medical devices.
  • 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.
  • 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.
  • Every Organ Wasted is a Life Not Saved.
  • TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide.
  • Maximize your potential at TransMedics, Inc.

Compensation

  • TransMedics is committed to equitable and transparent compensation.

Benefits

  • Lead end-to-end program execution for complex medical device systems that integrate capital equipment, disposables, and embedded software components.

Company info

  • 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.
  • Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant.
  • Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do.

Visa & Work Authorization

  • Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships
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This listing is sourced directly from TransMedics's careers page and normalized into a canonical job model.