Note: The job is a remote job and is open to candidates in USA. Viant Medical is a global medical device partner providing design, development, manufacturing, and assembly services. The Process Engineer is responsible for leading advanced process development across the full lifecycle of molding and manufacturing programs, applying expert scientific molding and cavity pressure control principles to deliver robust, optimized processes.

Responsibilities

• 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)

Skills

• 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)
• 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)
• Excel, PowerPoint, Word, and general computer skills
• 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
• Authorized to work in the U.S
• Spanish proficiency
• Ability to travel up to 75% to Viant sites (U.S., Costa Rica, Tijuana, and Vega Baja, PR)
• Certification in Basic Mold Flow (or equivalent) is a plus
• Certification in Master Molding 3 is a plus
• Plastics—Injection Molding; LSR (preferred)
• SolidWorks (drawing); 3D printing/3D software (preferred)

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