Senior Test Engineer

Position Summary

TransMedics is seeking an experienced Senior Test Engineer – Manufacturing Test Automation to design, develop, implement, and support automated manufacturing test systems for our innovative Organ Care System (OCS) technology. This is a hands-on engineering position focused on building and improving automated production test stations, developing test software, troubleshooting electrical and electromechanical systems, and ensuring reliable, repeatable manufacturing test processes.

Key Responsibilities

Automated Test Development & Programming

• Design, develop, program, validate, and deploy automated manufacturing test stations, including test 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 testing, PCBA testing, leak and flow testing, and integrated electromechanical system testing.
• Replace subjective or manual inspection processes with automated, quantitative, and repeatable measurements using defined acceptance criteria and pass/fail limits.
• Develop reliable production test software incorporating error handling, data logging, traceability, and diagnostic capabilities.
• Support new product introduction (NPI) and transition of test equipment and processes from development into manufacturing.

Manufacturing Test Systems & Production Support

• Troubleshoot, maintain, and improve existing production test stations to minimize downtime and improve equipment reliability, test throughput, and manufacturing efficiency.
• Diagnose hardware, software, electrical, PCBA, and electromechanical system failures using oscilloscopes, digital multimeters, power supplies, DAQ systems, and other test instrumentation.
• 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 opportunities for process improvement.
• 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.

Test Data, Validation & Quality

• Integrate automated test equipment with Manufacturing Execution Systems (MES), databases, and other data collection platforms to support accurate, searchable, and 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 established 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.

Cross-Functional Collaboration & Technical Support

• Partner with Engineering, Manufacturing, Quality, and Operations teams to continuously 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.

Minimum Qualifications

• Bachelor's degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 8 years of engineering experience, including manufacturing test engineering, test automation, electrical testing, or related engineering responsibilities.
• Minimum of 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, data acquisition systems, and related equipment.
• Strong hardware and software troubleshooting skills, including the ability to investigate failures and identify root causes.
• Ability to work directly on the 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.

Preferred Qualifications

• Demonstrated 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, including 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.