Job Description:
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
• 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. • Works 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. • Writes and performs validation activities for new and existing production test equipment and fixtures. • Creates, implements, and maintains test software in the LabView environment for existing and new programs. • Creates, revises, releases, and maintains test procedures through controlled document change order procedures. • Supports development of PCBA hardware and software solutions and supports transition to contract assembly suppliers, where applicable. • Supports Engineering team and Production team efforts to identify opportunities to streamline production through process, test, and product design changes. • Supports Technical Service activities including OCS system troubleshooting and upgrades. • Provides mentorship and guidance to technicians and junior-level engineers. • Provides training in testing, troubleshooting, and inspection methods as required. • Works 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. • Performs 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.
Employee Benefits:
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision 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.