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Principal Tooling Engineer

Viant Medical -
Remote

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Job Details

Full-time

Qualifications

Foreign language proficiency
Mold repair (production tasks)
Statistics
Customer communication
Defect resolution root cause analysis
ISO standards
Quality control statistical data analysis
CAD design (engineering design task)
Process simulation software
Manufacturing facility experience
Production validation processes
Medical device manufacturing facility experience
Customer engagement
Molding process implementation
Schedule creation
Biomedical regulatory compliance
Engineering design modification
Microsoft Project
Technical Proficiency
FDA regulations
Failure analysis
Engineering quality assurance

Full Job Description

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).

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

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.

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tooling engineer jobs

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