Test Engineer (Contractor)

TransMedics, Inc.; Andover (MA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical with HRA through BCBS MA

Dental

Vision

Healthcare FSA

Dependent Care FSA

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Test Engineer to design, develop, troubleshoot, and debug testers and test procedures to support manufacturing and development of the Organ Care System.

You will create LabView-based tests for PCBA and system levels, define test parameters with Design and Manufacturing Engineering, and write/validate production test equipment and fixtures while maintaining compliance with cGMP/QSR/ISO standards. Training and collaboration across teams are a key part of the role.

Qualifications

• BS in Engineering plus 4 years of experience in FDA/ISO regulated Medical Device/Equipment Industry.
• Experience fabricating and validating test equipment/procedures.
• Knowledge of LabView programming; IPC standards; Six Sigma a plus.

Responsibilities

• Develops hardware and software tests for PCBA and system level tests (LabView).
• Collaborate with Design and Manufacturing Eng to set test parameters and coverage.
• Write/validate production test equipment and fixtures; maintain tests.
• Create, implement and maintain LabView test software for new and existing programs.
• Maintain leak and flow test equipment; ensure compliance with quality systems.
• Create, revise and release test procedures per document control.
• Assist in transitioning board-level tests to contract assembly suppliers.
• Support Engineering and Production to streamline through process and design changes.
• Support Technical Service activities including OCS troubleshooting and upgrades.
• Assist QA to maintain cGMP/QSR/ISO compliance; participate in training.

Skills

LabView

PCBA testing

Test software

Validation

cGMP/QSR/ISO

Six Sigma

Electrical testing

Education

Bachelor's in Engineering

Tools

IPC Standards

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.

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.

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.

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 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.