Requirements: English
Company: Sixtema Srl - Ricerca e selezione del personale
Region: Mirandola , Emilia-Romagna
Project manager / Intelligence engineeringResponsible to lead and coordinate the execution of critical to business programs from concept development through manufacturing transfer and commercialization. The Responsibilities will include the management of disposable programs leading to the transformation of organ transplant in the US and worldwide.This is a high visibility role, requiring decisive judgment and interaction with multiple internal and external teams. The ideal candidate is a technically capable, results-oriented leader with experience in developing and implementing program management tools to successfully execute programs.Manage project tasks, Gantt charts and resources, communicate with stakeholders, and address any issues that arise, often working with multiple engineering, Quality and Operations disciplines.Work in close cooperation with the engineering members and RA/QA to coordinate the tasks leading to the submission strategy and with Operations to ensure the introduction and the scalability of the new products in the Manufacturing line.Key ResponsibilitiesDefine the Project plan and build Gantt charts working in close cooperations with all the functions impacting the ProgramInvolve internal and external technical resources to support the programsWork collaboratively with product development, manufacturing engineering, and quality teams to execute programs on time and on budgetBuild and implement program management tools and processes to effectively execute programsTimely tracking and presentation of program statusPerform other TransMedics tasks and duties as requiredRequirementsLeadership role responsible for managing programs10+ years experience in FDA/ISO regulated complex medical device development with emphasis on perfusion systems5+ years of experience in similar role as Engineering Intellingence / Project ManagerDetail oriented with strong organizational skillsStrong leadership and interpersonal skillsStrong program management skills with accountability for budgets, Gannt charts, milestones, and deliverablesExcellent verbal and written communication skills in English; Italian language skills are preferredEffective analytical and decision making skillsMust have a proven history of working in a fast-paced environment with a demonstrated ability to adjust to changing prioritiesBroad experience in design of medical devices and manufacturing processes of disposables, polymeric, biomedical device environment, measurement systemsMaster''s degree or PhD in Biomedical Engineering, Mechanical Engineering, or related fieldAbility to bring disruptive medical technologies from concept to commercializationExperience with Class III devices, extracorporeal (ECMO) technology and life-critical medical devices strongly preferredExperience managing projects in multi-disciplinary technical teamsProven track record leading Programs to successful product launches and commercializationAbility to work in an international environmentHighly motivated to enhance products, techniques and consequently the life of the patientsWillingness to relocate to Mirandola, Italy