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About the job

Job Description:

POSITION SUMMARY

The Test Engineer designs, develops, troubleshoots and debugs testers and test procedures to support manufacturing and development of TransMedics Organ Care System.

RESPONSIBILITIES

Develops hardware and software solutions used to test PCBA level and system level functional tests including but not limited to LabView PCBA testing, leak and flow testing, electrical testing and system functional testing.

Work with Design and Manufacturing Engineering 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 tests related to the implementation and validation of Production Test Equipment and fixtures.

Create, implement and maintain test software in the LabView environment 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 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.

Work with Quality Assurance to maintain an approved internal Quality System that meets the

requirements of cGMP’s, QSR and ISO requirements.

Provide training in testing, troubleshooting and inspection methods as required.

Perform other TransMedics tasks and duties as required

MINIMUM QUALIFICATIONS:

BS in Engineering plus 4 years of experience working in a FDA/ISO regulated Medical Device/Equipment Industry; or equivalent combination of education and experience.

PREFERRED QUALIFICATIONS

Proven experience in fabrication and validation of test equipment/procedures of Electro- Mechanical and functional test equipment in a FDA/ISO regulated Medical Device/Medical Equipment Industry.

Must possess expertise in 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.

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.

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.

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.