Process Engineer

🔥 32 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👷🏻‍♀️ Engineer

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Viant Medical

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🤝 B2B

💰 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.

📋 Description

• Lead the process development cycle • Evaluate processes for robustness, accuracy, and optimization • Initiate improvement projects • Quality/Metrology support: Assist site QE on KPI/KPO impacting part quality and process control • Partner with GTS/Site Tooling Engineer on design requirements • Partner with Tool Engineer 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 I.Q. and O.Q. runs; report required • Complete other related projects and tasks assigned • Demonstrate expert knowledge and performance • Apply scientific molding (Decoupled 2 and Decoupled 3) • Expert in cavity pressure monitoring and control (RJG) • Join technical reviews with customers and mold shops • Support DFM and tool design reviews with Tool Engineers • Support molding cell development and execution • Support EOAT design and fabrication • Manage mold shop deliverables and expectations (SIM reports) • Confirm receiving-site requirements (press/shot size/tonnage/special sequence) and machine capability studies • Develop processes, review Moldflow data for start-up and debug • Travel to customer sites, tool shops, and Viant facilities as needed; trip report required • Prepare, track, and communicate Process DOEs, report results and recommendations • Manage multiple concurrent projects (minimum 20 active)

🎯 Requirements

• Bachelor of Science Degree in Engineering or related plastics discipline or 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). • Certification in Basic Mold Flow (or equivalent) is a plus. • Certification in Master Molding 3 is a plus. • 10+ years of experience in processing and in a molding environment, process development, qualification, validation of molds, etc. • Extensive knowledge and able to train in: processing and process development techniques in scientific molding principles (MM2 skill level) • Plastics—Injection Molding; LSR (preferred) • Excel, PowerPoint, Word, and general computer skills; SolidWorks (drawing); 3D printing/3D software (preferred) • Some knowledge in FDA, QSR, and ISO 13485 medical device regulations and standards. • Understanding of statistics, Cp & Cpk studies for process. 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 the various engineering grade thermoplastic resins and Mold Flow analysis.

🏖️ Benefits

• Travel Requirement: 75% travel across Viant locations in the US but mainly to Costa Rica, Tijuana, BC, and Vega Baja, PR sites.