Principal Tooling Engineer

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Viant Medical

5001 - 10000 funcionários

🏥 Saúde

🏭 Manufatura

🤝 B2B

💰 Private equity em 2017-01

Healthcare • Manufacturing • B2B

A Viant Medical é uma fabricante contratada e parceira de design de produtos focada em dispositivos médicos. A Viant oferece serviços completos, incluindo design e desenvolvimento de dispositivos, fabricação clínica-comercial e produção escalável com capacidade de sala limpa e presença global para ajudar OEMs a acelerar o tempo de lançamento no mercado. A empresa se posiciona como um parceiro de fonte única para engenheiros e fabricantes de dispositivos médicos que buscam um desenvolvimento mais rápido, pronto para regulamentação e opções de produção responsiva onshore/regional.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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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