At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** Job Specific Summary Une carrière chez Medtronic ne ressemble à aucune autre. Nous sommes déterminés. Nous sommes engagés. Et nous sommes motivés par notre mission : soulager la douleur, restaurer la santé et prolonger la vie de millions de personnes dans le monde. Dans ce rôle passionnant de microbiologiste en stérilisation, vous aurez la responsabilité de soutenir les validations de stérilisation des produits sur le marché. Vous aurez la responsabilité de soutenir le travail de stérilisation et de soutenir les changements apportés aux produits existants et l'introduction de nouveaux produits. Ces validations comprennent des validations de la stérilisation des produits, ainsi que des validations des produits et des processus. Le titulaire du poste fournit des solutions techniques pour obtenir des processus de stérilisation validés pour les produits nouveaux et existants. Il met à jour les procédures de stérilisation de routine et les spécifications correspondantes, et examine et publie les procédures de stérilisation de routine. Il soutient et dirige l'équipe dans l'évaluation des nouveaux produits ou des changements apportés aux produits existants. Les responsabilités peuvent inclure les éléments suivants et d'autres tâches peuvent être assignées. + Travailler de manière relativement indépendante, tout en bénéficiant des conseils et de l'orientation des membres de l'équipe et du directeur. + S'assurer que toutes les exigences de qualité sont conformes aux réglementations et aux spécifications des produits. + Vous êtes responsable de l'organisation et de la mise en œuvre de l'ensemble des activités de l'entreprise, y compris de la gestion des ressources humaines. + Effectuer, coordonner, exécuter et résumer tous les domaines de la validation de la stérilisation (EtO et radiation). + Travailler avec peu de conseils pour concevoir et valider les cycles de stérilisation pour les nouveaux produits, y compris les rapports IQ/OQ/PQ des nouveaux stérilisateurs, l'étalonnage et le soutien à la production. + Le travail avec peu d'encadrement consiste à développer, mettre en œuvre et maintenir les processus de stérilisation, les certifications et les procédures pour les opérations de stérilisation au sein de Medtronic. + Soutenir les audits internes et externes + Préparer des réponses écrites aux questions réglementaires + Examiner les ordres de modification de l'ingénierie. + Résoudre les problèmes de non-conformité et mettre en œuvre des mesures correctives. + Travailler avec la maintenance des installations et d'autres départements pour toutes les activités d'amélioration/correction des stérilisateurs, des CEA ou des laboratoires. + Participer aux projets spéciaux qui lui sont confiés. + Examiner les notifications de contrôle des modifications apportées par les fournisseurs (SCC) pour déterminer leur impact sur la stérilisation et les essais microbiens. + Participer activement avec le service des achats à l'expertise technique microbiologique pour la sélection et la certification des fournisseurs de composants. + Il s'assure que la fonction microbiologie/stérilisation est maintenue selon les normes de l'industrie. Doit posséder : Exigences minimales Pour être considéré pour ce poste, veuillez vous assurer que les exigences minimales sont évidentes dans votre curriculum vitae. + Baccalauréat en sciences ou dans un domaine technique avec plus de 2 ans d'expérience en microbiologie, stérilisation et/ou biocompatibilité OU Diplôme d'études supérieures en sciences ou dans un domaine technique avec plus de 0 ans d'expérience en microbiologie, stérilisation et/ou biocompatibilité. Ce qu'il faut + Spécialiste certifié en stérilisation industrielle (CISS) + Expérience de la validation de la stérilisation par rayonnement + Connaissance approfondie des principes, méthodes et procédures fondamentaux de la microbiologie, y compris la connaissance de la morphologie et de la coloration des bactéries, ainsi que des techniques aseptiques, en particulier en ce qui concerne les méthodes de stérilisation. + Expertise en matière de surveillance de l'environnement (EM). + Expertise en matière d'exigences relatives aux salles blanches et aux tenues vestimentaires. + Capacité à effectuer plusieurs tâches à la fois, à planifier, organiser et coordonner des projets et à travailler de manière indépendante. + Capacité à rédiger des protocoles, des rapports, des procédures et des instructions de travail. + Capacité à lire et à interpréter des documents relatifs à la stérilisation des dispositifs médicaux et aux salles blanches, y compris : Normes internationales, réglementations, procédures techniques, revues, publications réglementaires. Familiarité avec les réglementations de la FDA. + Connaissance pratique de MS Word, Excel, PowerPoint, MS Outlook, Project. + Expertise en matière de BPF et de systèmes de qualité relatifs aux dispositifs médicaux stérilisés en phase terminale. + Connaissance des méthodologies et techniques officinales (AAMI, USP, ISO). ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. In this exciting role as an Microbiologist - Sterilization you will have responsibility for supporting on market product sterilization validations. You will have responsibility for sustaining sterilization work and to support of changes to existing products and the introduction of new products. These validations include product sterilization validations, along with product and process validations. The position provides technical solutions to achieve validated sterilization processes for new and existing products. Updates to routine sterilization procedures and related specification, and review and release routine Sterilization. Supports and leads team with assessments of new products or changes to existing products. Responsibilities may include the following and other duties may be assigned: • Work relatively independently with guidance and direction from senior members of the staff and manager. • Assure all Quality requirements are in compliance with regulations and product specifications • Provide new product development sterilization / microbiology validation support • Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO, and radiation) • Work with little guidance to design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support. • Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Medtronic. • Support internal and external audits • Prepare written responses to regulatory questions • Review engineering change orders. • Resolve non conformances and implement corrective action • Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities. • Participate in special projects as assigned. • Reviews Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing. • Actively involved with Purchasing department for microbiological technical expertise to the in the selection and certification of component vendors. • Assuring that the Microbiology / Sterilization function is maintained per industry standards. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. + Bachelor's degree in Science or technical field with 2 years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced degree in science or technical field with 0 years of work experience in microbiology, sterilization, and/or biocompatibility experience Nice to Have • Certified Industrial Sterilization Specialist (CISS) • Experience in Radiation Sterilization validation • Thorough knowledge of fundamental microbiology principles, methods, and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods. • Environmental Monitoring (EM) subject matter expertise. • Expertise in clean room requirements and gowning requirements • Ability to multi-task, skilled in planning, organizing, coordinating projects, and working independently. • Ability to write protocols, reports, procedures, and work instructions • Ability to read and interpret documents related to medical device sterilization and cleanrooms Including: International standards, regulations, technical procedures, journals, regulatory publications. Familiarity with FDA regulations. • Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project • Expertise in cGMP’s and quality systems as related to terminally sterilized medical devices. • Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) **Welcome to our new Careers Site!** **If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com