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 III, 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 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 lead-time.
If indicators show an adverse trend, works with the functional team to plan and implement appropriate 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 equipment, 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.Participates 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).Leads or supports CAPA investigation processes, or exception documents such as complaints investigations.Leads or supports continuous improvement projects for any of the main key areas: safety, quality and production.Provide technical assistance to non-exempt personnel, being accountable for their correct training and performance managementRequired QualificationsBachelor's Degree in STEM careers.4+ years of working experience on similar roles.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.Familiar with Lean manufacturing concepts and continuous improvementmethodologies.Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.Experience in project management.Willing to travel.Fully bilingual English - Spanish (required)Preferred Qualifications1-3 years prior experience in medical devices manufacturing.Performance management.