Senior Test Engineer
TransMedics, Inc. · Andover, Massachusetts, US
Job Description: POSITION SUMMARY We are seeking a results-driven Senior Test Engineer with experience in the medical device industry to join our test engine...
Job description
Job Description: 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 verifications testing including system, environmental, usability, biocompatibility, reliability, sterility, and safety testing. - Manage requirements and ensure traceability to all protocols and specifications. - Write verification and validation protocols based upon requirements and user needs. - Design and validate new test methods and test fixtures. - Release a...