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Process Engineer

đź•’ August 20

🤠 Texas – Remote

infoinfo

⏰ Full Time

đźź  Senior

đź”´ Lead

👷🏻‍♀️ Engineer

đź‘» Ghost score 19%

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🗣️🇪🇸 Spanish Required

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Logo of Viant Medical

Viant Medical

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🤝 B2B

đź’° Private equity on 2017-01

Healthcare • Manufacturing • B2B

Viant Medical is a contract manufacturer and product design partner focused on medical devices. Viant provides end-to-end services including device design & development, clinical-market manufacturing, and scaleable production with clean-room capabilities and a global footprint to help OEMs accelerate time to market. The company positions itself as a single-source partner for engineers and medical device manufacturers seeking faster regulatory-ready development and responsive onshoring/regional production options.

đź“‹ Description

• Lead the process development cycle across molding and manufacturing programs • Evaluate processes for robustness, accuracy, and optimization • Initiate improvement projects • Provide quality and metrology support for KPIs/KPOs impacting part quality and process control • Partner with GTS/site tooling engineers and tool engineers on design and development requirements • Support business development by selling tooling solutions and resolving processing issues • Support corrective actions, re-validations, and tool/process optimization • Oversee process development through IQ and OQ runs and report results • Apply scientific molding using Decoupled 2 and Decoupled 3 principles • Manage cavity pressure monitoring and control using RJG principles • Participate in technical reviews with customers and mold shops • Support DFM and tool design reviews • Support molding cell development and execution • Support EOAT design and fabrication • Manage mold shop deliverables and expectations, including SIM reports • Confirm receiving-site requirements and conduct machine capability studies • Develop processes and review Moldflow data for startup and debugging • Travel to customer sites, tool shops, and Viant facilities; submit trip reports • Prepare, track, and communicate process DOEs, results, and recommendations • Manage a minimum of 20 concurrent projects • Serve as a technical interface between Viant, customers, tool shops, and internal teams • Support NPI, sustaining engineering, and business development initiatives • Ensure regulatory compliance and best-in-class production outcomes

🎯 Requirements

• Bachelor of Science Degree in Engineering or related plastics discipline, 4-year engineering degree, or equivalent completion of a 4,000 hour or 2-year process engineering apprenticeship • Certification from a school in advanced molding or RJG Master Molder 2 (or equivalent) • Fully bilingual in English and Spanish • 10+ years of experience in processing and in a molding environment, process development, qualification, and validation of molds • Extensive knowledge of processing and process development techniques in scientific molding principles (MM2 skill level) • Knowledge of plastics injection molding; LSR preferred • Proficiency with Excel, PowerPoint, Word, and general computer skills • SolidWorks drawing experience • Knowledge of 3D printing/3D software preferred • Some knowledge of FDA, QSR, and ISO 13485 medical device regulations and standards • Understanding of statistics and Cp & Cpk studies for process • Understanding of I.Q., O.Q., and P.Q. requirements • Strong understanding of DOE methods and implementation • Expert knowledge of cavity pressure technologies and advanced control principles • Familiarity with engineering-grade thermoplastic resins and Mold Flow analysis • Authorized to work in the U.S. • Ability to travel up to 75% to Viant sites in the U.S., Costa Rica, Tijuana, and Vega Baja, Puerto Rico

🏖️ Benefits

• Remote work model • Travel opportunities to Viant locations, customer sites, and tool shops

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