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Materials Engineering & Applied AI

Iver
Olsen

Fifteen years solving materials, quality, and regulatory problems in medical device manufacturing taught me exactly where technical teams lose time. Now I build the AI that gives it back: a materials certification pipeline, automated lab reporting that saves our scientists hundreds of hours a year, and a RAG system that answers technical questions straight from the standards. I build for engineers and scientists because I've been both.

15+
Years Experience
$500M
Portfolio Supported
85%
Plating FPY From 11%
500+
Lab Hours Saved / Year
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About

Iver Olsen

I see the gap before it's a problem

I started as a lab tech, running tensile tests and prepping metallographic samples, learning how materials behave before I ever managed anyone. The technical foundation matters, but what stuck with me was everything around it: what it's like to be the person doing the careful, detailed work, what gets glossed over by the people relying on it, and how technical expertise turns into results the rest of the business can use. Those lessons shape how I lead now.

That foundation carried me through seven years in medical devices, then to Houston to build a quality system from scratch and get an energy-sector failure analysis lab accredited, and on to A-dec, where I now lead the materials and clinical engineering function for a global dental manufacturing operation.

The pattern across all of it is the same: I see the gap, whether it's a missing lab, no quality system, no process, or no data, and I figure out how to stand it up, prove it works, and make it stick. Sometimes that means pointing the gap out to people who haven't noticed it yet. It's meant building an ISO 17025 quality system from scratch, turning around a plating line that was scrapping nearly nine parts in ten, standing up a BSL-2 microbiology program, and writing the EU MDR strategy for a $140M device portfolio. Lately the gap has been software: my teams were losing days to manual document searches and report writing, so I learned to build the AI tools that give that time back, with a bias toward systems that stay traceable and auditable instead of just demoing well.

The technical work is only half of it. The other half is building the team that carries it further than I could alone: engineers and scientists who trust each other, who stay, and who become the people their colleagues call when something breaks.

I hold a BS in Materials Science & Engineering from the University of Utah, am ISO 13485 auditor trained, and completed Lean Six Sigma Black Belt coursework. I was one of four engineers chosen from 7,500 worldwide to present original research at TE Connectivity's annual conference in Prague.

ISO 13485ISO 17025EU MDR Failure AnalysisSEM / EDSPython Analytics Lean Six SigmaProcess ValidationElectroplating BiocompatibilityPLM SystemsKPI DevelopmentApplied AI/ML
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Areas of Practice

The areas I work in, spanning materials and quality engineering and the AI tooling I build to support them.

Materials Engineering
Materials selection, failure analysis, and characterization across medical device, energy, and precision manufacturing. Most of my career has gone into understanding why materials behave the way they do and specifying the right ones for the job.
Failure AnalysisMaterials SelectionSpec DevelopmentSEM/EDSFT-IRXRF
Applied AI/ML
Production AI tooling for engineering and quality teams, built and deployed, not prototyped. A RAG system over our technical standards, a materials certification pipeline, and automated lab reporting that saves hundreds of scientist hours a year. I work deterministic-first: AI handles the genuinely ambiguous parts, while evaluation and audit logic stay rule-based and traceable.
PythonRAG & LLM ToolingAutomation WorkflowsAzureFastAPIscikit-learn
Root Cause Analysis
Structured problem-solving for manufacturing and quality issues. I start with the process rather than the symptom: mapping the system, identifying the critical-to-quality factors, and driving to root cause before anyone jumps to a fix.
Fishbone DiagramsCTQsProcess MappingDMAIC
Quality Management Systems
Design, implementation, and remediation of ISO 13485 and ISO 17025 quality systems. I've built QMS programs from scratch and led teams through accreditation and audit cycles.
ISO 13485ISO 17025QMS DesignAudit Prep
Regulatory Compliance
EU MDR strategy, FDA 21 CFR Part 820 compliance, and technical file authorship for Class I, II, and III medical devices.
EU MDRFDA 21 CFR 820Technical FilesPMCFRisk Assessment
Process Validation
IQ/OQ/PQ protocol development and execution for manufacturing processes and test methods, aligned to ASTM, ISO, and FDA standards.
IQ/OQ/PQASTM / ISOTMVBiocompatibility
Process Improvement
DMAIC-driven improvement for high-scrap manufacturing lines. Plating, extrusion, assembly: I diagnose the bottleneck, put controls in place, and get first-pass yield where it needs to be.
DMAICRoot CauseSPCLean
Lab Strategy & Analytics
Laboratory insourcing strategy, KPI framework development, and Python-based analytics for engineering and quality teams. I've built lab programs from the ground up and developed the metrics to prove they work.
PythonKPI DesignLab InsourcingData Visualization