Medical Device & Biomedical Engineering

Design, prototyping, and engineering for Class I & II medical devices — concept to production, by a biomedical engineer who's shipped real hardware.

What I do

Services

  • Automated Design-Controls Documentation

    Design inputs and outputs, verification & validation records, and design history file assembly — generated from the design process as it happens, not reconstructed afterwards. I've produced these by hand across real device programs; now I build the AI that does it.

  • CAD & Design

    Full-range CAD — parametric modeling, surfacing, free-form sculpting. Native CAD, STL/OBJ, and manufacturing drawings.

  • In-House 3D Printing

    Professional FDM/SLA printers up to 300×300×605 mm, in flexible, tough, heat-resistant, and biocompatible materials.

  • Prototyping

    Proof-of-concept through pre-production, with design-for-manufacturability built in from day one.

  • Reverse Engineering

    Turn a physical part or scan into an editable 3D model to replicate, modify, or improve.

  • FEA & Verification/Validation

    Analysis and V&V to prove designs meet spec — before they ship.

  • Machining & Injection Molding

    CNC parts through ISO-compliant suppliers; injection-molding optimization and basic mold design.

  • 3D Renderings & Animation

    Photoreal renders and animation for sales, marketing, and training.

  • Design Improvement & CAPA

    Component redesign and corrective action to improve quality, manufacturability, and cost.

Selected work

Real devices, designed and built.

A sample of hardware I've taken from concept through design, printing, testing, and iteration.

Let's find the highest-value thing to automate first.

Book a free opportunity call — we'll find where this would save you the most, then I'll build you a short demo on your own workflow. No pitch, no obligation.

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