Test Engineer (Contractor)

TransMedics, Inc.•Andover, MA

About The Position

The Test Engineer designs, develops, troubleshoots, and debugs testers and test procedures supporting manufacturing and development of the TransMedics Organ Care System. The role develops hardware and software solutions for PCBA-level and system-level functional testing, including LabView PCBA testing, leak and flow testing, electrical testing, and system functional testing. The Test Engineer works with Design and Manufacturing Engineering to develop test parameters and requirements, validate production tests and equipment, create and maintain LabView test software, and implement and maintain leak and flow test equipment. The position also maintains controlled test procedures, transitions board-level functional tests to contract assembly suppliers where applicable, and supports production improvements, technical service troubleshooting and upgrades, quality-system compliance, and employee training.

Requirements

Bachelor of Science in Engineering plus 4 years of experience working in an FDA/ISO-regulated medical device or equipment industry, or an equivalent combination of education and experience.
Expertise in electronic testing, troubleshooting, and repair of printed circuit boards.
Strong organizational and interpersonal skills, attention to detail, and clear, effective communication.
Ability to work in a fast-paced environment and adjust to changing priorities.
Effective analytical and decision-making skills, with a focus on quality and accuracy to meet corporate quality and regulatory requirements.
Ability to identify, prioritize, and resolve issues with minimal supervision.

Nice To Haves

Proven experience fabricating and validating test equipment and procedures for electromechanical and functional test equipment in an FDA/ISO-regulated medical device or equipment industry.
Experience with IPC standards, including J-STD-001, IPC-A-610/620, and IPC-7711/7721; formal training or certification is a plus.
Knowledge of LabView programming; formal training is a plus.
Formal Six Sigma training is a plus.

Responsibilities

Develop hardware and software solutions for PCBA-level and system-level functional tests, including LabView PCBA, leak and flow, electrical, and system functional tests.
Work with Design and Manufacturing Engineering to establish test parameters and requirements that evaluate design requirements and minimize gaps in test coverage.
Write and perform validation activities for new and existing production tests associated with implementing and validating production test equipment and fixtures.
Create, implement, and maintain LabView test software for existing and new programs.
Implement and maintain existing and new leak and flow test equipment.
Create, revise, release, and maintain test procedures through controlled document change order procedures.
Transition board-level functional tests to contract assembly suppliers where applicable.
Support Engineering and Production teams in identifying opportunities to streamline production through process, test, and product design changes.
Support Technical Service activities, including OCS system troubleshooting and upgrades.
Work with Quality Assurance to maintain an approved internal Quality System meeting cGMP, QSR, and ISO requirements.
Provide training in testing, troubleshooting, and inspection methods as required.
Perform other TransMedics tasks and duties as required.