Senior Test Engineer

TransMedics, Inc. • Andover, MA

7d • $118,600 - $148,000 • Onsite

About The Position

TransMedics is seeking an experienced Senior Test Engineer to design, develop, implement, validate, deploy, and support automated manufacturing test systems for its Organ Care System (OCS) technology. This is a hands-on engineering role focused on building and improving automated production test stations, developing test software, troubleshooting electrical and electromechanical systems, and ensuring reliable, repeatable manufacturing test processes. The engineer will own test systems from concept through development, validation, production deployment, and ongoing support, replacing manual, operator-dependent testing with objective, data-driven pass/fail criteria to improve reliability, throughput, and product quality.

The role works closely with Manufacturing Engineering, Quality, Product Development, and Operations. It supports new product introduction and production testing in a regulated manufacturing environment, including test-system integration with manufacturing data platforms, equipment qualification and validation, controlled documentation, investigations, and continuous improvement. The position is onsite at the company's Andover, Massachusetts location. It has no direct people-management responsibilities, though it may include technical mentorship and project guidance. Travel may include up to 10% domestic and 5% international travel.

Requirements

• Bachelor's degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, or a related engineering discipline.
• At least 8 years of engineering experience, including manufacturing test engineering, test automation, electrical testing, or related engineering responsibilities.
• At least 3 years of experience working in a regulated industry.
• Hands-on experience developing, troubleshooting, or supporting automated test systems for electrical, electronic, or electromechanical products.
• Experience programming or maintaining automated test applications using LabVIEW, TestStand, Python, C#, or similar test automation tools.
• Working knowledge of test and measurement instrumentation, including oscilloscopes, digital multimeters, power supplies, and data acquisition systems.
• Strong hardware and software troubleshooting skills, including investigating failures and identifying root causes.
• Ability to work directly on a manufacturing floor and collaborate effectively with production technicians, engineers, and quality personnel.
• Strong analytical, problem-solving, documentation, and communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Nice To Haves

• Experience independently designing, programming, validating, and deploying complete automated production test stations.
• Hands-on proficiency developing automated test applications using NI LabVIEW and/or TestStand.
• Experience with automated electrical and PCBA testing, test fixtures, signal measurement, and integrated electromechanical systems.
• Background in FDA-regulated medical-device or medical-equipment manufacturing, particularly complex capital equipment or integrated electromechanical devices.
• Experience with MES integration, SQL databases, automated test-data collection, and serial-number-level product traceability.
• Experience with equipment qualification, IQ/OQ/PQ, Gage R&R, measurement system analysis, and test method validation.
• Familiarity with communication protocols such as GPIB, SCPI, RS-232, Ethernet, CAN, SPI, or I2C.
• Experience with machine vision, automated inspection, signal analysis, or other quantitative testing methods.
• Knowledge of statistical process control (SPC), production yield analysis, and manufacturing test optimization.
• Experience with PLCs, industrial controls, sensors, actuators, or automated manufacturing equipment.
• Familiarity with IPC standards, including J-STD-001, IPC-A-610/620, and IPC-7711/7721.
• Experience with fixture design, CAD tools, calibration, and equipment maintenance.
• Familiarity with Git or other version control systems and software validation practices.
• Six Sigma training or certification.

Responsibilities

• Design, develop, program, validate, and deploy automated manufacturing test stations, including fixtures, instrumentation, data acquisition systems, and control software.
• Develop, implement, and maintain automated test applications using LabVIEW and other applicable programming environments.
• Develop subsystem hardware and software solutions and system-level functional tests, including electrical, PCBA, leak and flow, and integrated electromechanical testing.
• Replace subjective or manual inspection with automated, quantitative, repeatable measurements using defined acceptance criteria and pass/fail limits.
• Develop production test software with error handling, data logging, traceability, and diagnostic capabilities.
• Support new product introduction and transition test equipment and processes from development into manufacturing.
• Troubleshoot, maintain, and improve production test stations to reduce downtime and improve reliability, throughput, and manufacturing efficiency.
• Diagnose hardware, software, electrical, PCBA, and electromechanical failures using test instrumentation and related equipment.
• Partner with Manufacturing Engineering and Product Development to define test requirements, parameters, coverage, and acceptance criteria.
• Analyze production test data to identify failure trends, yield issues, test escapes, and process-improvement opportunities.
• Support PCBA hardware and software test development, including transition to contract manufacturing partners when applicable.
• Provide hands-on troubleshooting and technical support for OCS manufacturing, sustaining engineering, and Technical Service activities.
• Integrate automated test equipment with MES, databases, and other data collection platforms to support accurate, searchable, traceable production test results.
• Develop and execute equipment qualification and validation activities, including IQ/OQ/PQ, Gage R&R, and other measurement system analysis methods as applicable.
• Establish and maintain test procedures, software documentation, equipment specifications, calibration requirements, and work instructions.
• Create, revise, release, and maintain controlled documentation through engineering change order processes.
• Participate in process risk assessments, PFMEA, DFM/DFA reviews, root-cause investigations, and corrective-action initiatives.
• Collaborate with Quality Assurance to maintain compliance with applicable FDA Quality System Regulations, cGMP, ISO 13485, and internal quality requirements.
• Partner with Engineering, Manufacturing, Quality, and Operations teams to improve test coverage, product quality, and manufacturing efficiency.
• Train and support manufacturing technicians and operators on automated test equipment, troubleshooting methods, and inspection procedures.
• Provide technical mentorship and guidance to technicians and junior-level engineers.
• Support equipment vendors, manufacturing partners, and cross-functional engineering projects as needed.
• Perform other related duties as assigned.

Benefits

• Medical insurance with Health Reimbursement Account through Blue Cross Blue Shield of Massachusetts
• Dental insurance
• Vision insurance
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short-Term Disability
• Long-Term Disability
• 401(k) Retirement Savings Plan
• Pet insurance
• Employee Stock Purchase Plan
• May be eligible for bonuses and equity

What This Job Offers

• Job Type: Full-time
• Career Level: Senior