Senior Test Engineer

TransMedics, Inc.•Andover, MA

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. 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. MANAGEMENT RESPONSIBILITIES This position will not have management responsibilities PHYSICAL ATTRIBUTES General Office and Lab Environment, may sit for extended periods of time. Up to 10% Domestic Travel Up to 5% International Travel Ability to lift up to 25lbs. MINIMUM QUALIFICATIONS Bachelor’s Degree in Engineering 8 plus years of experience working in a regulated industry PREFERRED QUALIFICATIONS 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. Every Organ Wasted is a Life Not Saved. 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. Maximize your potential at TransMedics, Inc. https://www.transmedics.com/ TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $118,600-$148,000, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

Requirements

Bachelor’s Degree in Engineering
8 plus years of experience working in a regulated industry

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.