Microbiólogo-Esterilizador I

Medtronic plc; Tijuana; Híbrido; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

Medtronic plc à Tijuana, Mexique, recherche un Microbiologiste-Stérilisateur I pour superviser les analyses, préparer et stériliser les instruments et suivre les protocoles qualité. Le candidat appliquera des méthodes microbiologiques avancées et contribuera à l'amélioration continue des processus.

Diplôme requis en ingénierie biomédicale ou chimique, au moins 3 ans d'expérience dans l'industrie des dispositifs médicaux; maîtrise des normes ISO et anglais technique pour documentations et

Formación

• Diplôme de génie biomédical, génie chimique ou domaine connexe.

Responsabilidades

• Analyse des produits microbiologiques et tests dans le cadre du programme qualité.

Conocimientos

Expérience matériel médical

Réglementation & système qualité

Stérilisation EtO

Microbiologie & tests

Endotoxines & B&F tests

ISO standards

Anglais technique

Analyse statistique

Educación

Licence en génie biomédical ou chimique

Descripción del empleo

## Microbiologiste-Stérilisateur IPostuler: Sur site: Tijuana, Baja California, Mexico: Temps plein: Offre publiée hier: R78358Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type** Responsibilities may include the following and other duties may be assigned.* Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.* Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.* Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.* Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.* Develops, validates, and implements controlled environment methods.* Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.* Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.* May also be involved in establishing requirements for the transfer of methodology from R&D. **TECHNICAL SPECIALIST CAREER STREAM:**An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.**DIFFERENTIATING FACTORS****Autonomy:**Entry-level individual contributor on a project or work team. Works with close supervision.**Organizational Impact:**Delivers work of limited scope, typically smaller, less complex projects or related activities.**Innovation and Complexity:**Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.**Communication and Influence:**Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.**Leadership and Talent Management:**N / A – job at this level is focused on self-development.**Required Knowledge and Experience:*** **Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, or a related discipline.*** **Minimum of 3 years of experience within the medical device industry with knowledge of regulatory and quality system requirements.*** **Solid understanding of sterilization process methodologies, including Ethylene Oxide (EtO) and radiation sterilization.*** **Experience in microbiological and sterility testing methods, including Bioburden and Sterility Suitability (Bacteriostasis & Fungistasis – B&F).*** **Experience performing Bacterial Endotoxin testing and microbiological laboratory analysis.*** **Knowledge and hands-on experience with EO Biological Indicators, including validation, handling, and interpretation.*** **Strong knowledge of international standards including ISO 14644, ISO 14698, ISO 11135, and ISO 11137.*** **Experience with cleanroom technology, including airflow balancing, system functionality, and filtration systems.*** **Proficiency in advanced statistical techniques for data analysis, process monitoring, and continuous quality improvement.*** **Advanced English communication skills for technical documentation, reporting, and cross-functional collaboration.**Exigences physiques du posteLes déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.