Test Technician-Med-Device

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 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.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following: 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.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis. This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

Laboratory Environment Ability to lift up to 30 pounds and carry equipment from one workstation to another Exposure to loud or distracting noises. Standing or sitting for extended periods of time during laboratory testing.

MINIMUM QUALIFICATIONS

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.

PREFERRED QUALIFICATIONS

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. As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. TransMedics is committed to equitable and transparent compensation. The expected hourly rate for this role is $35.02 - $43.73, which represents the company's current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ's natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. - aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.