What I've built
Tools
Engineering calculators and planning tools for mechanical design, verification, and regulated product development.
Planning Tools
Design control documentation for medical device development — traceability, risk analysis, and V&V planning aligned with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Design Control
Requirements Traceability
Map user needs through system requirements, design inputs/outputs, verification methods, and acceptance criteria — with regulatory clause traceability, development phase tracking, and trace-health scoring for FDA 21 CFR Part 820.30 and ISO 13485 submissions.
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Risk Analysis
FMEA Risk Analysis
Build DFMEA/PFMEA risk tables with severity, occurrence, detection, RPN scoring, hazardous situation and harm analysis, residual risk acceptability per ISO 14971, mitigation ownership, and CSV export for design history files.
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V&V Planning
Design Verification Planner
Plan verification and validation activities by requirement — specify V&V type, test phase, sample rationale, acceptance criteria, protocol IDs, regulatory clause references, and evidence links for FDA submission and ISO 13485 design control packages.
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Test Methods
Test Protocol Library
Define test protocols from design requirement to measurable output — specify test conditions, equipment, acceptance criteria, and sample rationale. Cross-link each protocol to V&V plan entries (DV-xxx), requirements (REQ-xxx), and FMEA risk controls (FM/UR/PF-xxx) with clickable badges across all planning tools.
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Quality System
ISO 13485 Checklist
Clause-by-clause audit-readiness tracker for ISO 13485:2016 §§4–8 — capture status, owner, and evidence reference for every QMS requirement. Custom rows for organization-specific obligations; cross-links into the FMEA, traceability, and design-verification tools.
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Engineering Calculators
Analysis utilities for sizing, selection, reliability, and manufacturing risk.
Mechanical Design
Tolerance Analysis
Worst-case, RSS, and Monte Carlo stack-up analysis. Find interference risks, resultant gaps, Cpk, and sensitivity breakdowns — all without a spreadsheet.
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Reliability Eng
Reliability Engineering Toolkit
Seven tools in one: binomial sample sizing, Weibull, Arrhenius aging, pass rate CI, demonstrated reliability, series system, and Cpk.
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Thermal Eng
Thermal Analysis
Conduction (flat, cylindrical, spherical), convection (natural + forced correlations), radiation, series resistance networks, fin efficiency, and transient lumped-capacitance cooling curves.
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Structural Analysis
Beam Bending Calculator
Bending stress, deflection, shear diagrams, and section properties for 5 cross-section types across multiple support and load configurations.
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Materials Eng
Material Selector
Filter 30+ metals, polymers, ceramics, and composites by operating temperature, tensile strength, density, corrosion resistance, and budget. Ranked by fit score.
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Bonding & Joining
Adhesive & Resin Selector
Filter 35+ adhesives — two-part epoxies, cyanoacrylates, polyurethanes, silicones, methacrylates, anaerobics, UV-cure, hot-melt, films and tapes — by lap shear, service temperature, substrate compatibility, gap fill, handling time, and budget.
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