Haniyeh Javankish

Eric Product

• Found a new method to measure the radial forces for the Eric product spheres and adding more details to the instructions of TM11056, achieved successful completion of TMV validation.

Sofia 45 Catheter Product

• Led end-to-end manufacturing process development and optimization for the Sofia 45 product across 15 manufacturing processes (MPs)
• Developed Critical-to-Quality (CTQ) inspection requirements covering all Sofia 45 inspection points
• Performed DOE, data collection, and documented process characterization for laser welding termination, coil termination, NiTi wire processing, plasma preparation and coating, body fusing, coil winding, engage liner and marker band placement.
• Documented tolerance and stack-up analyses
• Managed multiple manufacturing lines and led equipment relocation to establish an 11-station Sofia 45 production line
• Designed and collaborated on custom fixtures, including R2D2 engagement fixtures and marker band crimper
• Led pFMEA development and MP finalization to identify risks and support PV readiness
• Conducted capability studies (CpK), OQ testing, and defect analysis
• Conducted design and process studies to optimize marker band configuration, improving manufacturing efficiency

New J-Shape Coating Tower

• Evaluated and qualified new J-shape coating tower for production readiness
• Verified mechanical and software configurations for proper system operation
• Optimized process parameters to achieve consistent and repeatable performance

• Developed and completed Critical-to-Quality (CTQ) inspection requirements across 12 manufacturing processes for the Fred Omega product
• Updated and standardized 12 manufacturing processes (MPs) to improve instruction clarity, process accuracy, and visual documentation, ensuring alignment of tools, fixtures, equipment, and components
• Revised 8 engineering drawings by updating SolidWorks part and drawing files (SLDPRT/SLDDRW) to reflect new configurations and design changes
• Updated process flow documentation to reflect current manufacturing operations
• Designed and implemented a new oven fixture to improve process performance and prevent stent wire damage

• Led manufacturing process optimization initiatives, improving efficiency, quality, and compliance
• Supported Coil Line, Controller Line, and AVP (Azur Vascular Plug) with multiple validated manufacturing process (MP) improvements
• Executed process studies and qualifications, reducing reject rates by eliminating or adding steps
• Updated manufacturing instructions by adding tools, clarifying procedures, enhancing visuals, and strengthening inspection criteria
• Implemented line layout changes to improve workflow and productivity
• Trained operators to enhance technical skills and support complex manufacturing challenges

• Maintained training documents and quality records
• Supported audits and training coordination
• Collaborated with engineers and supervisors on training plans
• Managed basic training tools, matrices, and project updates
• Conducted and delivered 8-hour onboarding training for new employees

• Supported resolution of production and workflow issues
• Provided technical support and operator training
• Led basic process improvements and troubleshooting
• Ensured safety, quality inspections, and SOP compliance
• Performed partial IQ/OQ for fixtures and equipment