Test Technician-Med-Device

TransMedics, Inc.•Andover, MA

1d•Onsite

About The Position

We are seeking a skilled and detail-oriented Test Technician to support the testing and validation of medical device systems including capital equipment, disposable components, and software-enabled devices. The ideal candidate will execute test protocols, troubleshoot issues, and contribute to product development and verification efforts in a fast-paced, regulated environment.

Requirements

Associate’s degree or technical certification in Electronics, Mechanical Technology, Biomedical Engineering, or related field; Bachelor’s degree a plus.
2+ years of hands-on testing experience, preferably in the medical device or regulated industry.
Familiarity with testing tools such as multimeters, oscilloscopes, pressure sensors, flow meters, and data acquisition systems.

Nice To Haves

Experience executing formal test protocols and working in a controlled, documentation-driven environment.
Basic understanding of software interfaces, firmware behavior, and troubleshooting electronic systems.
Ability to interpret mechanical drawings, wiring diagrams, and engineering specifications.
Strong attention to detail, time management, and organizational skills.
Proficient in Microsoft Office and/or data logging tools; familiarity with LabVIEW, Python, or automated test tools a plus.
Strong organizational, prioritization, and time management abilities in a dynamic environment.
Experience working under design control and GMP/ISO 13485 quality systems.
Exposure to software-enabled or connected devices.
Familiarity with risk-based testing strategies and statistical methods for test data analysis.
Ability to work independently and collaboratively in a cross-functional environment.

Responsibilities

Set up and execute electrical, mechanical, software, and system-level tests on prototype and production-level medical devices.
Perform testing per protocols, procedures, and standards, including verification, validation, and environmental testing.
Support development and validation of test fixtures, automated test setups, and custom instrumentation.
Record and analyze test data, document results accurately, and provide feedback to engineering teams.
Maintain detailed and compliant test documentation including test reports, logs, and deviations.
Identify, troubleshoot, and document failures or anomalies during testing; work closely with engineers to isolate root causes.
Support R&D, quality, and manufacturing in evaluating design changes, supplier components, and product performance.
Ensure compliance with applicable quality system regulations (e.g., FDA 21 CFR 820, ISO 13485).
Participate in lab organization, calibration of test equipment, and maintenance of safety and cleanliness standards.
Assist in the build, setup, and teardown of prototype devices for testing and demonstration purposes.
Support reliability, usability, and life-cycle testing as required.
Maintain inventory of lab supplies, tools, and consumables.
Support calibration, preventive maintenance, and equipment qualification (IQ/OQ/PQ) programs.
Develop and enforce lab procedures, safety protocols, and compliance with applicable standards (OSHA, ISO 13485, FDA QSR, IEC 60601, etc.).
Support engineering and test teams by coordinating test scheduling, equipment availability, and technician support.
Schedule and prioritize test requests across departments while maintaining project timelines.
Procure lab supplies, equipment, and services in accordance with budget and project needs.
Train and supervise lab personnel, including engineers and technicians, ensuring adherence to good laboratory practices (GLP) and good documentation practices (GDP).
Implement quality control and data integrity across all testing efforts.
Collaborate with cross-functional teams (R&D, Quality, Regulatory, Operations) to support the testing needs of product development, sustaining engineering, and manufacturing.
Maintain clean, organized, and audit-ready lab environments at all times
All other duties as assigned.