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Tooling Engineer

hace 5 horas


Tijuana, México ICU Medical A tiempo completo

Job Summary The Tooling Engineer is responsible for overseeing the engineering of thermoplastic injection tooling with external custom molders as well as tooling run internally either at the Tijuana site or with sister plants. Essential Duties and Responsibilities • Securing thermoplastic injection tooling equipment with vendors as well as internally by keeping records of each tool up to date. • Maintaining tooling equipment running properly, oversees external and internal vendors to ensure tooling is properly maintained and minimum-maximum spare components are established and properly stocked. • Ensuring proper tooling lifecycle is established to create timely replacement schedules to prevent sudden tooling breakdowns and supply disruptions. • Ensuring clarity on the capacity of each tool with external and internal vendors to enable proactivity in capacity ramp-up schedules and better manage demand fluctuations. • Responsible for Procurement of Thermoplastic Injection Molds: a) Prepare Request for Quotation (RFQ) and establish scope of work with suppliers b) Specify tooling requirements with suppliers according to production needs, cavitation, injection system, ejection systems, steel type, surface finish, etc. c) Oversees tooling manufacturing from design approval to initial test with suppliers. d) Executes FAT Run with supplier and pushes any necessary adjustments or changes prior to approval. e) Upon approval of FAT tooling transfer to final location, hands over tooling asset to appropriate function and ensures it is ready to begin validation. f) Oversees validation with appropriate functions and assists as needed to ensure successful validation and release to production. • Ensures all injection tooling is operating within its validation state. • Ensures that all tooling assets are properly recorded in the financial books for timely depreciation and disposal of obsolete tooling assets. Knowledge and Skills • Knowledge of tool room equipment and machinery required to repair, recondition and maintain injection tooling. • 3D modeling software for analysis and consulting, preferably Solid Works. • Skills in speaking, understanding, reading and writing the English language. Minimum Qualifications, Education and Experience • Bachelor's degree in the discipline of Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering or Degree in Engineering related to Manufacturing. • Minimum of 3 years of experience in the Medical Industry, the candidate understands the regulations of agencies such as FDA and Cofepris, clearly understands the validation process, the structure and statistical techniques for proper validation. • Scientific background in molding. Master Molder 1 or 2 preferred. • Experience using Lean Six Sigma tools for process/system improvements. • Experience managing custom molders and outside tool makers, primarily in the US. • Minimum of 3-5 years of hands-on experience in injection tooling procurement and specification, troubleshooting, transfer and validation.