Jobs at TransMedics, Inc.

Builds and maintains automated dashboards, reporting, KPIs, and analytical tools for transplant logistics. Mines and transforms large datasets using SQL and Python, applies statistical analysis, and delivers actionable insights to Product, Finance, Logistics, Clinical, and Technology teams. Supports logistics network design and evaluates big data technologies while translating business needs into scalable data solutions.

Develops and maintains real-time embedded software for medical organ-preservation devices across the full product lifecycle. Responsibilities include requirements analysis, risk assessment, software architecture, implementation, testing, verification, regulatory compliance, audit and FDA submission support, and field-complaint root-cause correction. The role also manages software development procedures and projects while collaborating with stakeholders. It is onsite five days per week and may require up to 20% combined domestic and international travel.

Supports TransMedics Organ Care System use during organ retrieval, preservation, transport, assessment, and transplantation. Completes OCS certification and recertification, provides hospital training and customer support, manages inventory and shipments, participates in laboratory and R&D activities, communicates case updates, prepares documentation and case reviews, and travels to clinical sites. Requires extensive on-call availability, domestic travel, hospital-based work, and the ability to lift 75 pounds.

Supports TransMedics Organ Care System use during organ retrieval, preservation, transport, assessment, and transplantation. Completes certification across organ platforms, provides hospital training and customer support, manages inventory and shipments, participates in laboratory R&D and conferences, communicates real-time case updates, documents procedures, and presents case reviews. Requires extensive on-call availability, hospital-based work, domestic air travel, and the ability to lift 75 pounds.

Supports Organ Care System use during organ retrieval, preservation, transport, assessment, and transplantation. Completes device certification, provides hospital training and customer support, manages inventory and shipments, participates in laboratory R&D and conferences, communicates case updates, and prepares post-case documentation and reviews. Requires extensive on-call availability, hospital-based work, domestic air travel, and the ability to lift 75 pounds.

Supports TransMedics Organ Care System use during organ retrieval, preservation, transport, assessment, and transplantation. Completes OCS certification and annual recertification, provides hospital training and customer support, manages inventory and shipments, participates in laboratory R&D and conferences, communicates case updates, and prepares post-case documentation and reviews. Requires extensive on-call availability, domestic air travel, hospital-site work, and the ability to lift 75 pounds.

Leads the Manufacturing Engineering organization across advanced operations, sustaining engineering, process engineering, and technical field service. Drives manufacturing transformation, automation, robotics, DfX/DFM, product quality, reliability, scalability, and operational efficiency. Builds and develops a high-performing engineering team, manages cross-functional collaboration with R&D, Quality, and Supply Chain, and oversees engineering systems, infrastructure, contractors, co-ops, and interns.

Leads Systems Engineering strategy and organization for next-generation Organ Care Systems. Owns system architecture, requirements, design translation, verification and validation across electrical, mechanical, and software subsystems. Manages internal and external design teams, budgets, planning, regulatory compliance, human factors, and cross-functional partnerships with Quality, Supply Chain, Regulatory, and Clinical teams. This hands-on leadership role also develops department capabilities and supports detailed technical execution for complex medical devices.

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.

Leads pre- and post-market clinical trials for medical device products, overseeing study planning, start-up, monitoring, site interactions, regulatory reporting, data management, budgets, timelines, vendors, and closeout. Ensures compliance with FDA regulations, GCP, ICH, ISO standards, protocols, and SOPs. Prepares clinical documentation, manages trial communications and metrics, supports regulatory files, collaborates with study committees, and presents trial updates to management. Requires extensive clinical trial management experience and up to 25% 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.

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.