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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Test Engineer - **Company:** Transmedics Inc - **Location:** Andover, MA, United States - **Experience:** Expert - **Salary:** $118,600.0 - $148,000.0 - **Contract:** Permanent contract - **Skills:** Testing (Software), SolidWorks (CAD), Failure Mode Effects Analysis, Minitab, Verification and Validation (Software), Strategies of Testing - **Published:** May 19, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=ca35f414974996e1 ## About the Role * Ability to be onsite 5 days per week and lift 25lbs., * BS in Mechanical, Electrical or Biomedical Engineering * At least 8 years of experience with 2 years in a lead role for performing verification and validation testing on Class II or III medical devices. * Strong understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations * Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency. * Strong problem-solving skills with the ability to identify root cause for test failure. * Experience applying statistical techniques to determine sample sizes based on risk * Ability to work independently with high competency and little guidance * Strong written and verbal communication skills are required. * Ability to use laboratory equipment, hand and power tools. PREFERRED QUALIFICATIONS * Proficiency with Minitab and a Six Sigma Green Belt is strongly desired. * Basic knowledge using Solidworks 3D modeling is highly desired. ## Description Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships, 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 all test protocol and fixture documentation using change order process. * Test prototypes using laboratory equipment and document in DHF. * Execute V&V test protocols and write verification and validation reports. * Fabricate prototypes with assistance from technical support team (Machine Shop, Technicians and Designers) and suppliers. * Assist in software test validation, FMEAs, and Design Reviews. * Maintain test equipment to ensure calibration and preventative maintenance are performed. * Coordinate test activities with external testing partners. * Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. * This position will not have management responsibilities. ## Related Videos - [Excellent Software Testing](https://www.wearedevelopers.com/videos/87-excellent-software-testing) - [The Algorithm That Nearly Killed Me: When Testing Isn't Enough](https://www.wearedevelopers.com/videos/2110-the-algorithm-that-nearly-killed-me-when-testing-isn-t-enough) - [XR Demystified: Separating Facts from Fiction in 2024](https://www.wearedevelopers.com/videos/1117-xr-demystified-separating-facts-from-fiction-in-2024) - [SMART Test Automation - the experience of legacy transformation](https://www.wearedevelopers.com/videos/100215-smart-test-automation-the-experience-of-legacy-transformation) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Dirty Tests And How To Clean Them](https://www.wearedevelopers.com/videos/515-dirty-tests-and-how-to-clean-them) ## Related Articles - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [What is a Test Plan: Guide to Test Planning](https://www.wearedevelopers.com/magazine/191-what-is-a-test-plan-guide-to-test-planning) - [How to create a test plan for software testing](https://www.wearedevelopers.com/magazine/56-how-to-create-a-test-plan-for-software-testing) - [Should senior developers refuse interview coding challenges?](https://www.wearedevelopers.com/magazine/29-should-senior-developers-refuse-interview-coding-challenges) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk)