Test Engineer (Contractor)

TransMedics • Andover, MA

5d

About The Position

The Test Engineer designs, develops, troubleshoots, and debugs testers and test procedures supporting the manufacturing and development of the TransMedics Organ Care System. The role develops and maintains 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 establish test parameters and requirements, validate production tests and test equipment, and maintain test software, equipment, procedures, and fixtures. The position also supports production and engineering improvements, contract assembly supplier transitions, technical service troubleshooting and upgrades, quality-system compliance, and employee training in testing, troubleshooting, and inspection methods. Other TransMedics tasks and duties may be assigned.

TransMedics is a commercial-stage medical technology company focused on expanding access to viable donor organs and improving transplant care. The company plans to relocate its headquarters to Somerville, Massachusetts, by 2028; specific timing and role impact may vary.

Requirements

• Bachelor of Science in Engineering plus four 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.
• Detailed orientation, strong organizational and interpersonal skills, and the ability to communicate clearly and effectively.
• 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 ensure assignments 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 electro-mechanical and functional test equipment in an FDA/ISO-regulated medical device or medical equipment industry.
• Experience with IPC standards, including J-STD-001, IPC-A-610/620, and IPC-7711/7721.
• Formal training or certification in relevant IPC standards.
• Knowledge of LabView programming; formal training is a plus.
• Formal Six Sigma training.

Responsibilities

• Develop hardware and software solutions for PCBA-level and system-level functional tests, including LabView PCBA testing, leak and flow testing, electrical testing, and system functional testing.
• Work with Design and Manufacturing Engineering to develop test parameters and requirements that evaluate design requirements and minimize or eliminate gaps in test coverage.
• Write and perform validation activities for new and existing production tests related to implementing and validating 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 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 that meets cGMP, QSR, and ISO requirements.
• Provide training in testing, troubleshooting, and inspection methods as required.
• Perform other TransMedics tasks and duties as required.

Benefits

• Medical coverage with a 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) plan
• Pet insurance
• Employee Stock Purchase Plan

What This Job Offers

• Career Level: Mid Level