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TransMedics, Inc. · 2 weeks ago

Senior Project Manager, New Product Development

Andover, MA

Full-time

Hybrid

Senior Level

$132K/yr - $165K/yr

7+ years exp

TransMedics, Inc. is a commercial-stage medical technology company focused on transforming organ transplant therapy for patients worldwide. The Senior Project Manager will lead the design, development, and implementation of complex medical devices for organ transportation and preservation, ensuring compliance with regulatory requirements throughout the product lifecycle.

Health CareMedicalMedical DeviceService IndustryWellness

Responsibilities

Lead end-to-end project 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

Oversee design control activities, ensuring robust documentation, traceability, and regulatory readiness

Contribute to design history files (DHF), technical documentation, and submission packages

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

Collaborate with cross-functional teams (R&D, Quality, Regulatory, Clinical, Operations, and Commercial) to drive project execution

Serve as the primary point of contact for project communications, both internally and externally, including with senior leadership and strategic partners

Provide engineering expertise to support feasibility, prototyping, and manufacturing scale-up

Develop and review detailed design documentation, drawings, and specifications

Participate in design reviews, hazard analyses, and failure mode effects analyses (FMEA)

Support Design for Manufacturability (DFM) and Design for Assembly (DFA) efforts

Support design transfer and pilot production activities, troubleshooting issues related to product performance

Identify and implement process improvements to enhance project delivery, team efficiency, and product quality

Perform other TransMedics tasks and duties as assigned/required

Qualification

Medical Device DevelopmentRegulatory ComplianceProject ManagementMechanical EngineeringBiomedical EngineeringPMP CertificationCAD SoftwareCommunication SkillsProblem-Solving SkillsInterpersonal Skills