The Opportunity This position works out of our Costa Rica – Alajuela location in the Structural Heart Division.
In Abbott's Structural Heart (SH) business, our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.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 Understands product cost components and its interactions, (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 withing financial cycle.Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion.Able to navigate and execute activities on manufacturing systems for example, update routers, BOM's or to generate new part numbers and ZFINs.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.7+ years of manufacturing/process.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 cross functional teams.Fully Bilingual (English and Spanish)Preferred Qualifications5 years prior experience in medical devices manufacturing.Performance management experience preferred.