Principal Tooling Engineer

Emploi pas sur LinkedIn

🕒 il y a 8 jours

🗣️🇪🇸 Espagnol requis

🗣️🇺🇸🇬🇧 Anglais requis

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Viant Medical

5001 - 10000 employés

🏥 Santé

🏭 Fabrication

🤝 B2B

💰 Private equity en 2017-01

Healthcare • Manufacturing • B2B

Viant Medical est un fabricant sous contrat et un partenaire de conception de produits axé sur les dispositifs médicaux. Viant fournit des services de bout en bout, y compris la conception et le développement d'appareils, la fabrication clinique et commerciale, ainsi qu'une production évolutive avec des capacités de salle blanche et une présence mondiale pour aider les OEM à accélérer le temps de mise sur le marché. L'entreprise se positionne comme un partenaire unique pour les ingénieurs et les fabricants de dispositifs médicaux cherchant un développement rapide et conforme aux réglementations, avec des options de production réactive sur place ou régionale.

Description

• Support Project Managers throughout the tool build cycle • Provide support to site QE on how to measure dimensions, supporting correlation between Viant manufacturing location, mold shop, & customer, support measurement fixture design and manage fabrication • Work with Site Tooling Engineer on requirements throughout design. • Work with Process Engineer on requirements throughout design and development. • Provide engineering support for business development to sell tooling solutions and solve tooling issues. • Provide engineering support for existing tool modification and repairs. • Supervision of tooling bench inspection upon receipt at Viant facility and instruction to tool room employees for correct preparation to get the molds ready for validation as needed. • Provide tooling troubleshooting and advanced mold diagnostics support to the manufacturing locations • Lead structured root cause analysis and drive corrective actions in collaboration with site teams. • Support quoting and early customer engagements by providing tooling technical input. • Manage DFM including Drawing reviews with site Quality Engineers • Manage mold shop's deliverables & expectations • Confirm receiving site requirements including press designation • Travel to various customer sites, tool fabrication sites and Viant production facilities as needed.

🎯 Exigences

• Certification from a trade school in mold making or Associates Technical degree minimum or completion of a 4,000 hour or 2-year mold making apprenticeship. • Bachelor’s degree in engineering is a plus • 10+ years of experience in a mold repair shop environment, tool maintenance, building of new molds and components, design, qualification, validation, etc. • Experience in medical molding and/or other regulated manufacturing environments • Experience specifying, reviewing and improving tool designs • SolidWorks CAD software abilities, Excel, PPT, Word and MS Project • Knowledge in FDA, QSR, and ISO 13485 medical device regulations and standards. • Understanding statistics, Cp & Cpk studies for tool grooming. I.Q., O.Q. and P.Q. requirements • Understanding of Gantt charts for tool build schedules • Familiarity with the various engineering grade thermoplastic resins and Mold Flow analysis • Experience using mold simulation tools beyond general mold flow exposure (e.g., Moldflow, Moldex3D, Sigma Soft) to support tooling quotes and design decisions.

🏖️ Avantages

• Authorized to work in the U.S. • Spanish proficiency (Required): Fluent professional Spanish (spoken and written) • Ability to travel up to 75% to Viant sites (U.S., Costa Rica, Tijuana, and Vega Baja, PR) • High self-sufficiency and ability to work effectively across multiple sites with frequent short notice travel.

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