Billy Wang

About Billy Wang

Accomplished Design Engineer and ASQ-certified Six Sigma Black Belt (CSSBB) with extensive expertise in medical device and combination product design, development and manufacturing, including proficiency in Design Controls and cGMP, with a specialized focus on drug delivery systems. • Proven ability to lead and manage diverse cross-functional teams, with hands-on experience in technical feasibility assessment, product development, process improvement, and manufacturing from concept to market launch• Comprehensive understanding of regulatory frameworks, including FDA (21 CFR Part 820, Part 4, Parts 210 and 211) and EU (MDR-GSPR and Directive 2001/83/EC), along with quality management systems (ISO 13485, ICH Q10), risk management (ISO 14971), and compliance with industry standards (ASTM, ISO, ICH, USP, AAMI, IEC, ISTA).• Creative inventor credited with multiple patented medical technologies.

Experience

1. Principal Engineer - Combination Product Operations

   Amgen

   May 2022 — Present · Thousand Oaks, CA, US

   Leader in Combination Product design and development for biologics delivery • Leading cross-functional teams to develop user-centric combination products for self-administration and HCP use including reconstitution kits, prefilled syringes (PFS), autoinjectors (AI), on-body delivery systems (OBDS), and ophthalmic devices. • Driving the development of PFS and reconstitution kit platforms, accelerating clinical and commercial initiatives in subcutaneous and ophthalmic drug delivery.• Performing technical feasibility assessments and usability evaluations for novel drug delivery technologies in their early stages• Collaborating closely with external vendors and Contract Development and Manufacturing Organizations (CDMOs) to ensure the timely delivery of combination products, while overseeing project advancement• Serving as a committee member for the AAMI Needle-based Injection System (DPC-WG03), focusing on injectors, containers, and pen needles

Education

• University of Toronto

  BASc with Honours, Mechanical Engineering, Bioengineering

• Georgia Institute of Technology

  Ph.D., Mechanical Engineering

Skills

• Project Management
• Solidworks
• Research Proposals
• Sas
• Microsoft Word
• Dreamweaver
• Metrology
• Image Processing
• Igor Pro
• Rapid Prototyping
• Afm
• Labview
• Start-Ups
• Value Propositions
• Laser Cutting
• Imagej
• Pspice
• Matlab
• Ansys
• Business Development
• Autocad
• Microfluidics
• Abaqus
• Financial Analysis
• Photolithography
• Intellectual Property
• Scanning Electron Microscopy
• Biomems
• Photoshop
• Simulink
• Biomaterials
• Jmp
• Igor
• Ms Project
• I-Deas
• Biomedical Devices
• Cell Biology
• Comsol
• Fluorescence Microscopy
• Cell Mechanics