Jobs at TransMedics, Inc.

Schedules aircraft and crews for aviation missions in a 24/7 command center. Coordinates flight requests, crew availability, aircraft selection, dispatch changes, maintenance, FBO arrangements, permits, slots, NOTAMs, weather alternates, and hangar needs. Tracks crew duty times and ensures compliance with Part 91/135 regulations, company policies, and safety standards. Maintains aircraft and crew logs, manages delays and reroutes, and submits post-flight expense reports.

Leads electrical and systems engineering for medical devices, including architecture, design, testing, verification, manufacturing support, regulatory compliance, field issue resolution, and product lifecycle activities. Manages senior and principal engineers, contractors, and interns while overseeing department goals, project planning, budgets, schedules, design documentation, contract manufacturers, and cross-functional collaboration. The position is onsite five days weekly and requires up to 10% domestic travel.

Lead end-to-end development and sustaining engineering projects for complex medical devices, including capital equipment, disposables, and software-enabled systems. Manage schedules, budgets, resources, design controls, technical documentation, phase-gate reviews, risk analyses, design transfer, manufacturing scale-up, and regulatory readiness. Collaborate with R&D, Quality, Regulatory, Clinical, Operations, and Commercial teams while providing technical leadership, resolving issues, and improving project delivery and product quality.

Supports clinical use of TransMedics Organ Care Systems for lung, liver, and heart transplantation across Italy and other regions. Responsibilities include organ retrieval, preservation, transport, and assessment; on-call case coverage; clinical-site travel; equipment maintenance; customer and sales-team training; case reviews; site initiation; literature, market, and competitive analysis; and collaboration with clinical, commercial, and cross-functional teams.

Develops, delivers, and maintains training programs for document control, QMS processes, and compliance standards. Provides onboarding, instructor-led, and virtual training; evaluates effectiveness; maintains training records; tracks completion and competency; supports audits; manages curriculum assignments and training reports; and provides cross-functional training-system support.

Develop and validate manufacturing test equipment, software, fixtures, procedures, and processes for electro-mechanical medical devices. The role includes LabVIEW programming, leak, flow, electrical, and system testing; troubleshooting PCBA hardware; improving test coverage and production efficiency; supporting PFMEA, DFM/DFA, quality systems, documentation, and supplier transitions. The engineer also mentors junior staff and technicians and provides technical service support for Organ Care System troubleshooting and upgrades.

Maintains employee data and personnel files in Workday HCM, conducts data audits, resolves discrepancies, supports HR processes such as onboarding, open enrollment, performance cycles, merit increases, job changes, terminations, compensation updates, and reporting. Ensures data privacy, compliance, and accurate processing of confidential information while documenting procedures and responding to routine HR system inquiries.

Leads enterprise-system strategy and implementation for Finance and HR, translating business needs into system enhancements, configurations, workflows, and functional requirements. Drives process standardization, automation, data governance, reporting reliability, compliance, validation, stakeholder alignment, vendor management, user adoption, and change management across a regulated organization.

Lead cross-functional, end-to-end development and commercialization programs for complex medical devices integrating capital equipment, disposables, and software. Manage scope, schedules, budgets, risks, vendors, design controls, regulatory readiness, phase-gate reviews, and program metrics. Coordinate R&D, Quality, Regulatory, Clinical, Operations, and Commercial teams while improving project management processes and mentoring team members. Ensure compliance with FDA, ISO 13485, EU MDR, and related quality and regulatory requirements.

Leads TransMedics’ existing Andover manufacturing operation and builds the new Somerville facility. Responsibilities include manufacturing transformation, operational excellence, Lean and Six Sigma, automation, MES implementation, capacity planning, new product introduction, process validation, regulatory compliance, facility ramp-up, and organizational development. The VP advises executives on manufacturing strategy, investment, risk, footprint, and scalability while building a high-performing leadership team and quality-first culture.

Drive adoption and sales of TransMedics’ Organ Care System across UK heart, lung, and liver transplant programs. Develop transplant-center partnerships, expand the National Organ Care Program, manage strategic accounts, tenders, reimbursement initiatives, customer training, clinical engagement, inventory, orders, reporting, and congress participation. The role requires medical-device sales expertise, collaboration with healthcare professionals and government stakeholders, and leadership of OCS specialists.

Develop and maintain real-time embedded software for organ preservation medical devices. Responsibilities include requirements analysis, risk analysis, software design, implementation, unit and system testing, documentation, verification, regulatory compliance, root-cause analysis of field complaints, corrective actions, quality audits, and FDA submission support.

Leads enterprise network, cloud security, resilience, backup, and disaster recovery strategy. Establishes secure configuration standards, segmentation, zero trust, redundancy, failover, recovery objectives, and automation across global infrastructure. Oversees AWS resilience, recovery testing, ransomware protections, compliance alignment, and executive risk reporting. Builds and mentors a global network engineering team while partnering with technology, security, and third-party teams.

Supports electronic Quality Management System deployment and document control in a regulated medical device environment. Manages document creation, review, approval, distribution, revision, archival, formatting, records, change history, compliance monitoring, quality documentation scanning, training records, and system metrics. Collaborates with Quality, Regulatory, R&D, and Operations teams. Requires 3–5 years of documentation control experience, regulatory knowledge, eQMS familiarity, and Microsoft Office and PDF editing proficiency.

Supports clinical use of the Organ Care System for lung, liver, and heart transplantation across Italy and other regions. Responsibilities include organ retrieval, preservation, transport, and assessment; on-call case coverage; clinical-site travel; customer and sales-team training; case reviews; equipment maintenance; site initiation; literature and market analysis; and collaboration with clinical programs and commercial teams.

Operates as second-in-command on Phenom 300 aircraft, assisting the Captain with safe flight operations, FAA and company compliance, aircraft readiness, passenger and flight records, maintenance coordination, security duties, itinerary changes, and delay prevention. Requires extensive flight experience, ATP certification, an unrestricted passport, a first-class medical, prior captain experience, and the ability to pass background screening and lift 75 pounds.

Manages medical-device quality control activities, inspectors, and inspection processes. Develops and improves quality systems, oversees nonconformance investigations, supports manufacturing and new product development, and ensures compliance with FDA QSR, ISO 13485, MDSAP, and MDR requirements. Leads audits, continuous improvement initiatives, staff training, performance management, and complaint investigations while maintaining product quality and regulatory compliance.