The Opportunity This position works out of our Costa Rica – Alajuela location in the EP Division.
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 Manufacturing Engineer II, 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 in order to to meet established goals for safety, quality, cost and production.Maintains systems that support the monitoring of key performance indicators such as yield, nonconforming material or leadtime.
If indicators show an adverse trend, works with the functional team to plan and implement appropiate changes.Understands product cost components and its interactions, (direct & indirect material costs, MUV, labor, overhead).
Uses product cost knowledge to identify risks and opportunities.Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.Performs installation/validation activities for new or existent production lines, meeting regulatory requirements.
That includes equipments, process, product and test method validations.Estimates validation activities cost and assures it is budgeted withing financial cycle.Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion.Paticipates in the identification and investigation of Non-conforming products.
Uses Root cause problem solving techniques to identify and eliminate causes, implements controls and define preventive activities.Evaluates the financial, process or quality impact, derived from product & process changes.Uses statistical techniques to facilitate decision making and to draw conclusions from available data.Leads or supports local cross functional team activities.
Support/Lead global initiatives with other functions and sites (ie, RA, R&D, QA).Required QualificationsBachelor's Degree in STEM careers.6 years of manufacturing/process development experience.Statistical techniques knowledge (DOE, SPC) is required.
PE license is a plus.Computer software knowledge (Microsoft Word, Excel, Power Point).
Knowledge of FDA, GMP and ISO guidelines.Experience with continuous improvement methodologies.
Such as lean manufacturing techniques, value stream mapping, or similar.Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.Experience in project management.Willing to travel.Advanced command of English language (required)Preferred Qualifications3-5 + years prior experience in medical devices manufacturing.Performance management.