Principal Tooling Engineer

About the company:Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high quality, life enhancing products with scale and expertise to bring devices to market efficiently. Learn more at Viant Medical’s website or on LinkedIn. About the role:The Principal Tooling Engineer is a senior individual contributor providing advanced tooling support focused on on-site tool design, troubleshooting, and mold diagnostics to stabilize production across multiple Viant sites. The role leads/supports tooling execution from RFQ/DFM through build and qualification/validation (IQ/OQ/PQ), using structured root cause analysis and data-driven decisions to resolve complex issues and strengthen long-term robustness. This position also supports quoting and early customer engagements (tool concept and simulation-informed input) and serves as a key technical interface among Viant sites, customers, and tool shops to ensure alignment, compliance, and reliable production outcomes. What you'll do:  Tool fabrication cycle: Support Project Managers throughout the tool build cycle Project initiations 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. Bench inspection and I.Q., O.Q. runs must have a report. Other related projects and tasks assigned Site support & troubleshooting: 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 (including mold flow/simulation-informed recommendations as applicable). Provide technical support for tooling topics during NPI—supporting DFM reviews, mold start-up, and validation activities (IQ/OQ/PQ) in partnership with Program and Site teams. RFQ Submission: Concept mold configurations and requirements for quoting Lead technical reviews with the customer and mold shop Manage DFM including Drawing reviews with site Quality Engineers Tool design & compliance with tooling manual  Manage measurement fixture & EOAT design & fabrication Manage mold shop's deliverables & expectations Confirm receiving site requirements including press designation Tool development, review of metrology data for OOS conditions and development into grooming plans. Travel to various customer sites, tool fabrication sites and Viant production facilities as needed.  Prepare, track, and communicate project plans that specify project phases, tasks, task interdependencies and durations. Coordinate tasks and schedules. Requirements:  Education: 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 Years of Experience: 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  Job Knowledge:    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. Additional Requirements: 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. Demonstrated root cause analysis leadership for tooling related issues, including driving corrective actions with sites and external tool shops. Strong customer-facing technical communication skills (able to explain complex tooling topics clearly in early customer engagements and NPI phases).