Sustaining Engineer

ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables. Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients. Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care. Further information can be found at ICU Medical’s website: http://www.icumed.com/ ICU Medical is looking for a responsible for leading projects and tasks to resolve “on market” product design related changes that impact supply to products produced at the Monterrey facility. Responsibilities: Resolve product and component needs and issues to ensure continuity of supply for all on Market Product for the Monterrey facility. Work with the Supplier Change Notification process and Supplier Quality regarding any issues, changes, or updates to supplied resins, components and materials used for production in the Monterrey facility. Work with R&D, Quality, Regulatory, Design Assessors and Plant Engineering to test components and or product to document and make changes or updates to ICU product documentation. Prepare and execute Change Management documentation to include Commodity Specs, Drawings, Change Management Control plans and Design and Development Plans as needed to ensure continuity of components, materials, and packaging materials. Communicate with management to provide updates on project status and or contingency plans to ensure continuity of supply of components and materials used for on-market product. Coordinate with ICU groups to prepare and execute Validations for Medical Packaging and Accelerated Aging Studies. Prepare presentations, graphs, plans, forms, reports, etc. or any other documents required, according to the nature of activities. Follow the standard operating procedures, rules and regulations established by entities related to the manufacture of medical products. Work on special projects as they arise or other responsibilities typical of a Sustaining Engineering Position to support on market product. Minimum Qualifications, Education & Experience: Bachelor’s degree in Engineering from an accredited college or university is required. Minimum of 3 years in the medical device industry or a combination of medical device and pharmaceutical industry experience. Technical Knowledge and Skills: Working knowledge of products manufactured in the Monterrey facility. Minitab use for Statistics and Data Analysis. Microsoft Project. Ability to read technical specifications, drawings, and understand testing standards. Knowledge of plant quality requirements as to on market product. Strong communication skills for use in interfacing with internal and external suppliers and ICU management. Abilities Communicate with management to provide updates on project status and or contingency plans to ensure continuity of supply of components and materials used for on-market product. Follow the standard operating procedures, rules and regulations established by entities related to the manufacture of medical products. Planning and Decision Making Plan and communicate project schedules using Microsoft Project. Communicate project status with management. Decisions based on data information, sound Engineering rationale and collaboration with others within the Monterrey facility.

Location: Apodaca, Nuevo León, MX

Posted Date: 7/3/2025