Jobs at TransMedics

• Lead our existing Andover manufacturing operation and establish a high-performing Manufacturing Leadership Team accountable for Safety, Quality, Delivery, and Cost (SQDC).
• Drive the continued transformation of our existing manufacturing operations, establishing the processes, systems, capabilities, and operating discipline required to support significant growth.

Job Description:

TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure.

• 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.

• Work with relevant stakeholders to determine customer needs for secure embedded and digital software applications
• Elicitate cybersecurity software requirements to support customer needs

• Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes.
• Manage inspectors and inspection processes of medical devices. (1st shift)

• Define and maintain the enterprise architecture framework, standards, and principles across application, infrastructure, and data domains.
• Develop and own the enterprise technology roadmap, aligning it with TransMedics' business strategy, digital transformation objectives, and regulatory obligations.

• Assist Clinical team with development of disposable and accessory concepts.
• Develop electromechanical sub-systems with cross-functional team.

• Monitor supplier performance and drive improvement and resolution of non-conformances directly with supplier through corrective action process.
• Establish and report on supplier Key Performance Indicators (KPIs).

• Utilization of statistical data analysis for trending and investigation purposes
• Ability to communicate ideas and information clearly, effectively, and concisely

• Serve as hands-on, technical contributor in developing new products to support existing product lines with minimal oversight
• Document designs by constructing solid models, assemblies, and drawings with SolidWorks

• Responsible for the electrical architecture, design and testing for the Next Generation Organ Care System while ensuring compliance with project requirements and regulatory standards.
• Provide leadership, oversight and guidance to internal and external design teams for new and legacy products, complaint investigations, and obsolescence.