The Validation Partner for Startups that Go the Distance
Nothing puts me more in the zone than the combination of statistical analysis, critical thinking, and ingenuity that validation work demands. I still vividly remember the challenges encountered during my first Minitab analysis – pivoting to nonparametric methods to assess process capability – and the results, reducing a 100% inspection to an AQL 1.0 sampling plan, cutting quality inspection time in half.
Since then, I’ve continued to hone my validation skills, working in rapid, adaptable Silicon Valley medtech. I’ve advanced in manufacturing engineering roles, from sustaining line support to leading engineering and NPI validation strategies. I’ve supported small and mid-size medical device companies through critical milestones, including IPO and a strategic distribution partnership with Medtronic.
I’m Ryan Young, founder of Assure Validation. I’ve built my company on everything those programs taught me about what separates manufacturing operations that scale from ones that don’t.
Certifications
- Certified ISO 13485:2016 Lead Auditor
- Lean Six Sigma Green Belt
Education
- M.Eng. Bioengineering – UC Berkeley
- B.S. Mechanical Engineering – Hofstra University Magna cum laude
Location
- Based in Rotterdam, The Netherlands
- Serving U.S. and European clients remotely
Languages
- English – Native/Fluent
- Spanish – Fluent
I attained my Master’s in Bioengineering from UC Berkeley, where I focused on medical device manufacturing and quality engineering. I’m based in Rotterdam, The Netherlands — bringing U.S.-trained validation expertise and direct knowledge of FDA requirements to clients on both sides of the Atlantic, with primary focus across the U.S. and Europe. I’ve collaborated with suppliers and contract manufacturers across multiple countries, including on-site work in China, and bring that international experience to every engagement.
I’ve moved cross-country to California and across the ocean to The Netherlands because I’ve never needed perfect conditions before committing. That same instinct is what I bring to every engagement — I find the problem, I fix it, and I don’t stop until the system works.