(Contract) Design Quality Engineer

Job Description: POSITION SUMMARY TransMedics is currently seeking a Contractor to join the Design Quality Engineer team in Andover, MA. The Design Quality Engineer plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Ensure design controls process for the projects meets applicable regulatory, corporate, and customer QMS requirements Collaborate with cross-functional teams including engineering, manufacturing, project managers, and regulatory Support new product development and sustaining projects for complex electrical/mechanical systems with software and disposables Provide quality input to product user needs, requirements, and specifications Provide quality input to critical to quality specifications Support development of engineering design documentation Support design and process verification and validations activities such as protocols, test cases, reports and resolution of issues identified during testing Support design reviews and development of the design history file Drive overall risk management process, including System Risk Analyses, FMEAs, risk controls and verification of effectiveness Support Design Transfer activities Assist in preparation for regulatory submissions and provide support during audits and inspections Apply sound, systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Provide support during Corrective and Preventive Action (CAPA) activities and manage CAPAs when necessary Support enhancements and continuous improvements to Standard Operating Procedures (SOPs) Improve knowledge of design controls, risk management, testing, statistics, and design verification / validation Perform other Quality Systems related duties as required Perform other TransMedics tasks and duties as assigned/required. MINIMUM QUALIFICATIONS Bachelor’s degree in a technical field 3-5 years experience in medical device or relevant regulated industry PREFERRED QUALIFICATIONS Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971) Working knowledge of design development and application of risk management Ability to organize and prioritize workflow across multiple projects Excellent organizational and interpersonal skills working in a cross-functional team Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility System-level design and development experience Experience with Electromechanical medical devices Prior contribution to quality processes for control of design and development CQA certification 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. 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.