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From Inspiration to Operations

Turning ideas into prototypes and prototypes into products

I offer flexible Time & Materials consulting as well as several productized service packages. In a Time & Materials engagement, I partner with manufacturers to design and manufacture engineered products. These engagements include hands-on engineering and project management services to help solve the many diverse engineering challenges associated with design and manufacturing. Below is a list of typical tools, skills, and expertise involved in client engagements.

Mechanical & Metallurgical Engineering

  • CAD modeling and drafting: Solidworks
  • Prototype development and testing
  • Risk Analysis, Failure Mode Effects Analysis.
  • Material selection, testing, and sourcing
  • FEA-Finite Element Analysis,
Project Management, Engineering Lead

  • Design Transfer
  • Advanced Product Quality Planning
  • Supplier Development
  • Design and Production Documentation
Applied Data Science & Augmented Intelligence

  • Data Engineering
  • Data Analytics & Visualization
  • Machine Learning
  • NLP
  • KG-RAG Architecture

Studies: Binary Classification, Temperature Data, The Compact Wallet

Fixed-price packages that leverage AI with domain expertise in the loop

QMS Starter Kit: Typically a 3-session engagement for medical device startups. Using a custom KG-RAG with domain expertise in the loop, this package delivers foundational QMS SOPs such as Design and Development, V&V Testing, and Risk Management. That framework helps startups manage contractors and employees so early work contributes to a compliant Design History File from day one. [How I use KG-RAG]

Design Controls Starter Kit: For startups that understand user needs and have an early prototype or design, but lack a structured regulatory framework. This package starts product design traceability and risk management so work effort contributes to the Design History File right away. The same frameworks give the project transparency and a task structure a project plan can grow from. [How I use KG-RAG]

Mining MAUDE Data, Insights Report The FDA’s MAUDE database is public but messy. Thoroughly reviewing thousands of records is difficult, yet those records are strong objective evidence of product failure modes — useful for risk management, post-market surveillance, competitor evaluation, and 510(k) test planning. This package uses applied data science and iterative text mining to parse, categorize, and filter unstructured adverse-event narratives for targeted product codes. [Learn more / sample report — UNDER CONSTRUCTION]

Let’s explore opportunities for collaboration.

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