Product Development & Commercialization
I’ve contributed across the product development pipeline, from conducting user research and managing project timelines to collaborating across disciplines and ensuring FDA Design Controls compliance.
I’ve contributed across the product development pipeline, from conducting user research and managing project timelines to collaborating across disciplines and ensuring FDA Design Controls compliance.
User Research & Needs Assessment for Surgical Instruments
System Requirements Definition
Budget Plans
Project Gantt Timelines creation
Concept Sketches
Industrial Design: 3D Product Renderings with Solidworks Visualize
Shop Work & 3D Printing for Rapid Proof of Concepts
Hand Calculations & Finite Element Analysis (FEA) Simulations
PUGH Decision matrices
Multidisciplinary Collaboration
Solidworks CAD & PDM
Rapid in-house Prototyping
Collaboration with Vendors & Manufacturers
In Vivo Pig Studies for Device Validation
In Vitro Testing
Optics, Electronics, MEMS, Electro-Mechanical Integration
Electro-Mechanical Debugging
Design Verification: Test Protocols, Methods, Execution, and Reports
Design for Manufacturing: Sheet Metal, Extruded Plastic Tubing, Machining, 3D Printing
Design for Assembly: Build Fixtures, Assembly Tools
2D Engineering Part Drawings & GD&T
Tolerance Stack Analysis
Data Processing & Statistical Analysis
Design Controls: Traceability Matrix Creation
Risk analysis and mitigation
ISO 14971 Risk Management
Hazard Traceability Matrix