Ph3Overview /h3pbJob Description: /b This position is responsible for, but not limited to, the following: /pulliResponsible for the implementation and the optimization of robust manufacturing processes in Production ensuring that safety, effectiveness, quality and reliability of the devices are met. /liliLead PFMEA activities in coordination with other stakeholders. /liliGenerate and validate work instructions and test procedures. /liliSpecify, design, and install equipment, tooling and fixtures used in production. /liliParticipate in DFM and DFA activities to define manufacturing processes for new product and product improvement programs. /liliDevelop Critical to Assembly (CTA) requirements as required for manufacturing processes. /liliIdentify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GRR), and Statistical Process Control (SPC) techniques. /liliPerform other TransMedics tasks and duties as assigned/required. /li /ul h3Responsibilities /h3ulliResponsible for the implementation and the optimization of robust manufacturing processes in Production ensuring that safety, effectiveness, quality and reliability of the devices are met. /liliLead PFMEA activities in coordination with other stakeholders. /liliGenerate and validate work instructions and test procedures. /liliSpecify, design, and install equipment, tooling and fixtures used in production. /liliParticipate in DFM and DFA activities to define manufacturing processes for new product and product improvement programs. /liliDevelop Critical to Assembly (CTA) requirements as required for manufacturing processes. /liliIdentify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GRR), and Statistical Process Control (SPC) techniques. /liliPerform other TransMedics tasks and duties as assigned/required. /li /ul h3Management Responsibilities /h3ulliThis position will not have management responsibilities. /li /ul h3PHYSICAL ATTRIBUTES /h3ulliOffice environment /li /ul h3Minimum Qualifications /h3ulliBroad technical experience in FDA/ISO regulated biomedical device environment, manufacturing processes and equipment of disposables, polymeric, testing and characterization methods, measurement systems; /lili15+ years of experience in Process development and/or Process Engineering/Manufacturing of Class II and/or Class III medical devices; /liliDemonstrated experience in the selection and qualification of assembly equipment and automation, automated assembly methods, robotics, PLCs, automated inspection, fixture design, injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding; /liliLean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred; /liliEffective analytical and decision-making skills; /liliDetail oriented with strong organizational skills; /liliAbility to work in an international environment; /liliHighly motivated to enhance products, techniques and consequently the life of the patients; /liliExcellent communication skills in English; Italian language skills preferred; /liliDegree in mechanical / mechatronic / biomedical / physics engineering; /liliGood knowledge of Microsoft Office suite; /liliWillingness to relocate to Mirandola, Italy /li /ul pbEvery Organ Wasted is a Life Not Saved. /b 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. /p pDriven 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. /p pbMaximize your potential at TransMedics, Inc. /b /p pTransMedics 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. /p /p #J-18808-Ljbffr