The Opportunity This position works out of our Alajuela location. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.As the Sr Manufacturing Engineer, you will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; is also responsible for the activities related to installation and validation of production lines as well as the lifecycle management of equipment.What You'll Do Daily support to the manufacturing activities to meet established goals for safety, quality, cost and production.Based on key performance indicators data such as yield, nonconforming material or leadtime, may support activities focused on maintaining indicators under control.Prepares product and process reports by collecting, analyzing, and summarizing information and trends.Uses statistical techniques to facilitate decision making and to draw conclusions from available data.Understands product cost components and its interactions, ie direct & indirect material costs, MUV, labor, overhead. Uses product cost knowledge to identify risks and opportunities.Performs installation/validation activities for new or existent production lines meeting regulatory requirements. That includes equipment, process, product, and test method validations. Estimates validation activities cost and assures it is budgeted within financial cycle.Identifies, selects, and purchases equipment/fixtures considering production requirements, mass production implications, redundancy or line capacity expansion. Has direct relation with vendors to define equipment suitability.Has knowledge and expertise on product requirements and specifications. Understands potential risks related to product malfunctions. Evaluates the financial or process/product quality impact, derived from product & process changes. Uses statistical techniques to facilitate decision making and to draw conclusions from available data.Assures that production lines output meets the specifications of the product. Has clear criteria of conforming/ non-conforming product and the test methods used for verifying conformance.Able to navigate and execute activities on manufacturing systems for example, update routers, BOM's or to generate new part numbers and ZFINs. Coordinates the activities related to new ZFIN's implementation.Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them. Supports DL's & IDL's training process.May lead or serve as member on cross-functional project teams including local and global participants (i.e. RA, R&D, DQ, etc).Responsible for researching new technology and suggesting new machines to the appropriate purchasing managers and decision-makers.Participates in the identification and investigation of non-conforming products. Uses root cause problem solving techniques to identify and eliminate causes, implement controls, and define corrections, corrective actions, and preventive actions. Leads or supports CAPA investigation processes, or exception documents such as complaints investigations.Identify and implement continuous improvement projects for any of the main key areas: safety, quality, production, and cost, using the appropriate project management tools.Required QualificationsBachelor's degree in Technical Engineering fields such as: Electronic, Electrical, Mechatronics, Electromechanical, Chemical.7+ years of manufacturing/process development experience, at least 5 years prior experience in medical devices manufacturing.Statistical techniques knowledge (DOE, SPC) is required. PE license is a plus.Computer software knowledge (Microsoft Word, Excel, Power Point). Willing to travel.Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.Knowledge of FDA, GMP, and ISO guidelines is required.Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.Experience in project management involving coordination of crossfunctional teams.Fully Bilingual (English and Spanish).Available to work 100% on site (Coyol, Alajuela).Shift Administrative (Monday to Friday 8:00 am -5:00 pm).Preferred QualificationsPerformance management experience required.
