Join our Team atCreanova, at Como !
Create Innovate Healthcare Solutionsfor abetter quality of lifeCreanovais a leading B2B partner inMedical Device Development Contract Manufacturing, specializing in innovative(electro-)medical deviceswith plasticinjection moldedenclosures.For our facility in Como, we are seeking a highly skilledManufacturing Process Engineerto join our dynamic growing team.You will beresponsiblefor managing thedesign transfer to productionandseries-productionassembly lines for severalmedical devices .Key Responsibilities:
Lead and manage thedesign transferto production andvalidationof newmanufacturing and assembly line processesfor the setup of new series-production assembly lines of medical devices, including plastic injection molding and electronics (PCB);
Managethe entire series-production process of (recurring)internal ordersof the production lines under your responsability;
Defineandimplementnecessarycorrectiveandpreventative actionsin response to internal, regulatory, and customer audit requirements;
Foster a culture ofcontinuous process improvementwith a focus onquality, efficiency,andcost-effectiveness ;
Create, reviewandensure compliancewith Master Batch Records, internal operational procedures, Qualification/Validation plans, protocols and reports, and other essential GMP documents;
Plan and conducttrainingand development for employees regarding new processes;
Collaborate and ensure effective communication with internal departments (e.g. quality assurance, quality control and warehouse) as well as externally with suppliers and customers, to ensure seamless operations and timely release of goods.Preferred Qualifications:
Bachelor's or Master's Degreein a scientific, (bio-)engineering, technology or related discipline.
Proficient inEnglish (B1 level) ;
Minimum of5 years of experienceinmedical device manufacturingor a similar field.
Knowledge ofplastic injection moldingprocesses andelectronics manufacturing(PCB) is a plus;
Knowledge of ISO13485is desiarable;
Advanced computer skills and proficiency inMS Office Suite ;
Validdriver's license(B category);
Excellent organizational, communication, and analytical skills;
Proven ability to lead and manage teams, ensuring efficient and successful manufacturing operations.If you are ready to contribute to our passionate team dedicated to making a positive impact in the healthcare industry, we would love to hear from you! Join us at Creanova and be part of our mission to create innovative healthcare devices.