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, Viant delivers high‑quality, life‑enhancing products, leveraging scale and expertise to bring devices to market efficiently. About the Role The Principal Tooling Engineer is a senior individual contributor responsible for advanced tooling support, focused on on‑site tool design, troubleshooting, and mold diagnostics. The role leads or supports tooling execution from RFQ/DFM through build and qualification/validation (IQ/OQ/PQ), applying structured root‑cause analysis and data‑driven decisions to resolve complex issues and strengthen long‑term robustness. The position also supports quoting, early customer engagements, 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. Lead project initiations. Provide support to site QE on measurement techniques, correlation between Viant manufacturing location, mold shop, and customer, and manage measurement fixture design and fabrication. Collaborate with Site Tooling Engineer on requirements throughout design. Collaborate with Process Engineer on requirements throughout design and development. Provide engineering support for business development to sell tooling solutions and resolve tooling issues. Provide engineering support for existing tool modification and repairs. Supervise tooling bench inspection upon receipt at Viant facility and instruct tool room employees for correct preparation to ready molds for validation. Report bench inspection and IQ/OQ runs. Complete other related projects and tasks as 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. Provide technical support during NPI, supporting DFM reviews, mold start‑up, and validation activities (IQ/OQ/PQ) in partnership with Program and Site teams. RFQ Submission Develop 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. Ensure tool design and compliance with the tooling manual. Manage measurement fixture and EOAT design and fabrication. Manage mold shop deliverables and expectations. Confirm receipt of site requirements, including press designation. Develop tool, review metrology data for out‑of‑spec conditions, and integrate into grooming plans. Travel to customer sites, tool fabrication sites, and Viant production facilities as needed. Prepare, track, and communicate project plans detailing phases, tasks, interdependencies, and durations; coordinate schedules. Requirements Education Certification from a trade school in mold making or an Associate’s 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, new mold/build, design, qualification, and validation. Experience in medical molding and/or other regulated manufacturing environments. Job Knowledge Experience specifying, reviewing, and improving tool designs. Proficiency with SolidWorks CAD, Excel, PowerPoint, Word, and MS Project. Knowledge of FDA, QSR, and ISO 13485 medical device regulations and standards. Understanding of statistics, Cp & Cpk studies for tool grooming; IQ/OQ/PQ requirements. Familiarity with Gantt charts for tool build schedules. Knowledge of engineering‑grade thermoplastic resins and mold flow analysis. Experience using mold simulation tools beyond general mold flow (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). Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. #J-18808-Ljbffr Viant Medical