Senior Test Engineer

TransMedics, Inc.•Andover, MA

1d•Onsite

About The Position

POSITION SUMMARY: The Senior Test Engineer at TransMedics designs, develops, troubleshoots and debugs test equipment and processes to support manufacturing and development of TransMedics’ Organ Care System (OCS). Working closely with cross‑functional teams in Manufacturing Engineering, Quality and Product Development, this role defines, implements, and validates robust manufacturing test processes and procedures. The engineer develops and optimizes test methods to ensure Critical‑to‑Quality (CTQ) standards are met, supports risk assessment (PFMEA) and DFM/DFA efforts, and drives documentation such as work instructions and engineering change orders. This position offers hands‑on involvement in troubleshooting, test development and test maintenance in areas from prototype through production. This position is onsite in our MA location. Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships RESPONSIBILITIES This position is responsible for, but not limited to, the following: Develops subsystem hardware and software solutions and system level functional tests including but not limited to LabView testing, leak and flow testing, electrical testing and system functional testing. Work with Manufacturing Engineering and Product Development to develop test parameters/requirements to ensure that all design requirements are evaluated to minimize or remove all gaps in test coverage. Write and perform validation activities for new and existing production test equipment and fixtures. Create, implement and maintain test software in the LabView environment for existing and new programs. Create, revise, release and maintain test procedures through controlled document change order procedures. Support development of PCBA hardware and software solutions and support transition to contract assembly suppliers, where applicable. Support Engineering team and Production team efforts to identify opportunities to streamline production through process, test and product design changes. Support Technical Service activities including OCS system troubleshooting and upgrades. Provide mentorship and guidance to technicians and junior-level engineers. Provide training in testing, troubleshooting and inspection methods as required. Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of cGMP’s, QSR and ISO requirements. May provide mentorship and project management support for other engineers and technicians. Perform other TransMedics tasks and duties as required.

Requirements

Bachelor’s Degree in Engineering
3 plus years of experience working in a regulated industry
8 years total as an engineer

Nice To Haves

Proven experience in fabrication and validation of functional test equipment and procedures for electro-mechanical devices in a FDA/ISO regulated Medical Device/Medical Equipment Industry.
Experience with electronic testing, troubleshooting and repair of printed circuit boards.
Experience with IPC Standards including J-STD-001 Soldering Electrical and Electronic Components, IPC-A-610/620 PCB and Wire Harness Inspection and IPC-7711/7721 Rework and repair of electronic assemblies. Formal training/certification a plus.
Must be detailed oriented with strong organizational skills and interpersonal skills with outstanding ability to communicate clearly and effectively.
Knowledge of LabView programming, formal training a plus.
Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
Must have effective analytical and decision-making skills with a keen focus on quality and accuracy to ensure that all work assignments meet corporate quality and regulatory requirements.
Six Sigma formal training a plus.
Ability to identify, prioritize and resolve issues as they arise with minimal supervision.

Responsibilities

Develops subsystem hardware and software solutions and system level functional tests including but not limited to LabView testing, leak and flow testing, electrical testing and system functional testing.
Work with Manufacturing Engineering and Product Development to develop test parameters/requirements to ensure that all design requirements are evaluated to minimize or remove all gaps in test coverage.
Write and perform validation activities for new and existing production test equipment and fixtures.
Create, implement and maintain test software in the LabView environment for existing and new programs.
Create, revise, release and maintain test procedures through controlled document change order procedures.
Support development of PCBA hardware and software solutions and support transition to contract assembly suppliers, where applicable.
Support Engineering team and Production team efforts to identify opportunities to streamline production through process, test and product design changes.
Support Technical Service activities including OCS system troubleshooting and upgrades.
Provide mentorship and guidance to technicians and junior-level engineers.
Provide training in testing, troubleshooting and inspection methods as required.
Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of cGMP’s, QSR and ISO requirements.
May provide mentorship and project management support for other engineers and technicians.
Perform other TransMedics tasks and duties as required.