What are the responsibilities and job description for the Senior Manufacturing Quality Engineer position at TransMedics, Inc.?
Job Description: RESPONSIBILITIES This position is responsible for, but not limited to, the following: Utilization of statistical data analysis for trending and investigation purposes Ability to communicate ideas and information clearly, effectively, and concisely Provide quality engineering support in the manufacturing of medical devices & hardware Ensure compliance of manufacturing processes and areas to all applicable quality system regulations Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvements through analysis of trend data Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities Partner with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP) Partner with Manufacturing Engineering to implement and maintain electronic manufacturing and inspection work instructions within a Manufacturing Execution System (MES) Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards. Establish and maintain quality control procedures, including inspection methods and test protocols. Support internal and external auditing requirements in manufacturing to ensure compliance with quality system requirements Support other Quality Engineering functions as required (supplier quality, service, design QA) Perform other TransMedics task and duties as required MINIMUM QUALIFICATIONS § BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline. Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices. Experience with manufacturing of complex medical device products. Experience with medical capital equipment and electromechanical devices preferred. Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA. Experience with handling non-conforming material and assemblies. Experience with work instruction development and maintenance within an MES environment PREFERRED QUALIFICATIONS Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired. Experience with process validation Experience with non-product software implementation and validation Familiarity with Critical Manufacturing MES § Experience presenting data and information to management, including senior and/or executive management 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.
