3 validation engineer jobs found in Andover

Job Description: Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships POSITION SUMMARY We are seeking a results-driven Senior Test Engineer with experience in the medical device industry to join our test engineering team. This role is responsible for developing, executing, and overseeing the testing strategies that ensure the safety, reliability, and compliance of Class II/III medical devices in accordance with FDA and ISO 13485 regulations. The ideal candidate has a deep understanding of medical device lifecycle processes and a strong technical background in test systems, automation, and compliance in regulated environments. This position is based at our Andover, MA headquarters. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead test engineering activities for new development projects. Responsible for conducting feasibility and...

Job Description: POSITION SUMMARY The Senior Mechanical Sustaining Engineer will be supporting cross-functional sustaining engineering project teams. This is an important role for the company, providing engineering expertise to support products already on the market. The position requires a team-oriented individual with strong engineering RESPONSIBILITIES This position is responsible for, but not limited to, the following: 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 Fabricate prototypes utilizing internal and external resources Perform structural, dimensional, fluid, vibration, thermal, and reliability analyses to support new and existing product designs Work with internal and external manufacturing partners to ensure design for manufacturability and serviceability Prepare and lead design reviews, and...

Job Description: POSITION SUMMARY TransMedics is transforming organ transplantation through the Organ Care System (OCS), a breakthrough platform that preserves and assesses donor organs outside the body. Our Manufacturing Engineering team plays a critical role in ensuring safe, efficient, and scalable production of both disposable and capital equipment systems. The Manufacturing Engineering Intern will support production-related engineering activities associated with the manufacturing of the TransMedics Organ Care System. This role provides hands-on exposure to assembly processes, test systems, documentation control, and process validation within a regulated medical device environment. The intern will work closely with Manufacturing Engineers and be paired with a dedicated mentor to ensure meaningful project ownership and professional development throughout the program. RESPONSIBILITIES: This position is responsible for, but not limited to, the following: Manufacturing...