Descripción del empleo
Position Summary The EP Team in Heraeus Medevio is looking for a Manufacturing Engineer II or III to support its project portfolio. The selected person will work out of our Cartago facility and support the Electrophysiology Manufacturing organization by transferring, setting up and launching a manufacturing line in Costa Rica for Heraeus Medevio, and become the Senior Engineer in charge of the line once in Production. Essential Duties and Responsibilities Support new EP projects with Engineering activities during and after product transfers. Work towards fulfillment of external and internal customer requirements Support any other activity related to the role and projects requiring Engineering Support. Work in parallel and alignment with the Global EP R&D team for product launches and transfers. Estimate validation activities cost and assures it is budgeted within financial cycles. Estimate and understand product cost components and its interactions, (direct & indirect material costs, labor, overhead, variances). Once in production. daily support to the EP manufacturing activities to meet established goals for safety, quality, cost, and production. Use key performance indicators data such as yield, nonconforming material, or cycle time to act and initiate projects/initiatives to maintain indicators under control. Develop and execute on continuous improvement initiatives to improve efficiency in the manufacturing lines. Use statistics to facilitate decision making and to draw conclusions from available data. Prepare product and process reports by collecting, analyzing, and summarizing information and trends for Heraeus and its customers. When necessary, meet with external customers on project meetings and production performance reviews. Perform installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipment, process, product and test method validations. Ensures Manufacturing Procedures and Work Instructions are clear, effective and in compliance with regulatory and QMS requirements. Minimum Qualifications Degree in STEM careers appropriate for the functions and role. English is a must requirement. 5+ years’ experience in Manufacturing Sustaining and Transfer process is a must. Medical Device and Catheter experience preferred. Proficient with MS Word, Excel and other Microsoft Office tools. High analytical, organized and business/service oriented. Able to solve problem and think independently in a constantly changing medical device manufacturing environment. Statistical techniques knowledge (DOE, SPC, etc.) is required plus experience with continuous improvement methodologies, such as lean manufacturing, value stream mapping, or similar. Knowledge of FDA, GMP, and ISO guidelines is required. Demonstrated experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies. Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% – 15% travel) mainly between Minnesota, USA and Costa Rica Valid Passport and USA visa
