We are looking for a Technical Documentation Specialist for the Oncology line who will report to the Operation Manager and collaborate with the Research and Development (R&D), Production, Quality and Regulatory Affairs (QA&RA) departments. Functions and responsibilities : Manages the transfer of projects to production (design-transfer) and prepares hardware and software tools for carrying out the production process. Manages product/production process changes in accordance with ISO 13485, MDR 2017/745, 21 CFR part 820 and collaborates with RA for the correct documentation of the changes introduced, performing the necessary checks and validations. Keeps the Technical Documentation of medical devices updated in compliance with regulatory standards and manages the necessary communications with notified bodies, in collaboration with RA. Draws up and keeps up to date production manuals, device user manuals and labeling plans. Ensures the application to medical devices of the technical regulations in force on electrical safety, mechanical safety, biocompatibility, electromagnetic compatibility, usability. Collaborates with Research and Development for the definition of design requirements and analysis of the regulations applicable to medical devices and for the drafting of technical documentation. Interfaces with the design department and external suppliers to analyze the main technical problems and identify feasible solutions in the production department and/or in the development of new devices or modification of existing ones. Supports the production department in solving production problems with a view to continuous improvement, also through the implementation of hardware and software tools. Implement legislative updates in the technical documentation of the devices in collaboration with QA and RA. Collaborates with the Quality and AR System Manager to maintain the quality levels required in the performance of the production process. Supports audit activities by regulatory authorities and notified bodies. Requirements Degree in engineering (biomedical/electronics) or diploma of industrial expert with specialization in industrial electronics or similar (electrical engineering / mechatronics) Previous experience of at least two years in the Medical Device or Pharma & Life Sciences sector Ability to understand technical documentation such as: standards, directives, regulations, data sheets of electronic components, wiring diagrams, instrumentation user manuals Knowledge of the Medical Device Regulation (MDR 2017/745), 21 CFR part 820 and applicable standards (e.g., IEC 60601-1, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62304) Ability to draft technical documentation according to industry standards (MDR 2017/745, IEC 60601-1, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62304) Basic knowledge of electronics and ability to use laboratory devices, including: oscilloscope, multimeter, gaussmeter, signal generator, tester for measurements of dielectric strength, leakage currents and insulation resistance, soldering station, benchtop power supplies Knowledge of the main production processes (assembly, machining, etc.) Good knowledge and ability to use the main office applications (Word, Excel, Powerpoint, Visio) and management programs Good knowledge of written and spoken English Predisposition to learning, flexibility, analytical and problem-solving skills Good organizational skills and autonomous planning aimed at results. Posizione aperta: Ad integrazione del nostro Ufficio Tecnico siamo alla ricerca di una/un Technical Writer & Change Management Specialist che riporterà all'Operation Manager e lavorerà in stretta collaborazione con i team di Ricerca e Sviluppo (R&D), Produzione, Qualità e Regulatory Affairs (QA&RA). Settore: Medical Devices Dispositivi Medici Focus: Technical documentation e Change Management Location: Carpi (MO) Lavoro in sede Contratto: Tempo indeterminato Orario: Full-time Responsabilità principali: Gestire le Change Request di prodotto (Design Change) e di processo produttivo (es. Supplier Change Requests, Supplier Transfers), garantendo la conformità a ISO 13485, MDR 2017/745, 21 CFR part 820 e collaborando con Regulatory Affairs (RA) per la documentazione e la validazione delle modifiche. Aggiornare e mantenere la Documentazione Tecnica secondo gli standard normativi, interfacciandosi con enti notificati. Redigere ed aggiornare manuali e procedure di produzione, manuali d'uso e piani di etichettatura. Gestire le non conformità e le azioni correttive e preventive (CAPA), identificando ed implementando soluzioni per prevenire il ripetersi di problematiche. Supportare il Design Transfer ed il miglioramento continuo, predisponendo strumenti hardware e software per la produzione. Collaborare con fornitori esterni e R&D per la risoluzione di problematiche tecniche. Applicare normative tecniche relative a sicurezza elettrica e meccanica, biocompatibilità, EMC e usabilità. Collaborare con il responsabile Qualità e Regulatory Affairs per garantire il rispetto degli standard di qualità aziendali. Requisiti richiesti: Laurea in Ingegneria (Biomedica o affini) oppure Diploma tecnico con esperienza nel settore. Esperienza di almeno 2 anni in ambito Medical Devices oppure Pharma & Life Sciences. Conoscenza del Regolamento Dispositivi Medici (MDR 2017/745), 21 CFR part 820 e degli standard normativi (IEC 60601-1, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62304). Esperienza nella redazione di documentazione tecnica conforme agli standard del settore. Conoscenza dei principali processi produttivi (assemblaggio, lavorazioni meccaniche, stampaggio di materie plastiche ecc.). Ottima conoscenza di Microsoft Office e strumenti gestionali. Buona conoscenza della lingua inglese (scritta e parlata). Flessibilità, capacità analitiche, problem solving e autonomia organizzativa J-18808-Ljbffr