Manufacturing Process Optimization Engineer

hace 2 días


Alajuela, Alajuela, Costa Rica Abbott A tiempo completo

The Opportunity
We are seeking a skilled Manufacturing Process Optimization Engineer to join our team in Costa Rica – Alajuela, working within the EP Division of Abbott's Electrophysiology business.
Abbott is advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, enabling individuals to restore their health and live a fulfilling life.As this key role, you will develop and implement efficient manufacturing processes and methods that align with product specifications and quality standards; recommend and execute improvements to production processes, methods, and controls; and be responsible for activities related to installation and validation of production lines as well as equipment lifecycle management.

Key Responsibilities
  • Daily support to manufacturing activities to meet established goals for safety, quality, cost, and production.
  • Maintain systems supporting monitoring of key performance indicators such as yield, nonconforming material or leadtime.
  • If indicators show an adverse trend, work with the functional team to plan and implement appropriate changes.
  • Understand product cost components and its interactions (direct & indirect material costs, MUV, labor, overhead).
  • Use product cost knowledge to identify risks and opportunities.
  • Keep equipment operational by coordinating calibration, maintenance, and repair services; follow manufacturer's instructions and established procedures; request special service when needed.
  • Perform installation/validation activities for new or existing production lines, meeting regulatory requirements. This includes equipment, process, product, and test method validations.
  • Estimate validation activities cost and ensure it is budgeted within the financial cycle.
  • Identify, select, and purchase equipment/fixtures according to production requirements, due to obsolescence, redundancy, or line capacity expansion.
  • Participate in identifying and investigating Non-conforming products.
  • Apply Root cause problem-solving techniques to identify and eliminate causes, implement controls, and define preventive activities.
  • Evaluate the financial, process, or quality impact derived from product & process changes.
  • Use statistical techniques to facilitate decision-making and draw conclusions from available data.
  • Lead or support local cross-functional team activities. Also, support/lead global initiatives with other functions and sites (e.g., RA, R&D, QA).
Requirements
  • Bachelor'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.
  • Willingness to travel.
  • Advanced command of English language (required).


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