Credentials

Standards work and credentials

I don't just apply the standards; I've helped write and review them. That's useful when a requirement is ambiguous and you need to know what the committee was actually trying to achieve.

Standards development

Development team

IEC 62304:2006/AMD1:2015

Medical device software: Software life cycle processes

Development team

ANSI/AAMI SW91:2018

Classification of defects in health software

SME reviewer

IEC 82304-1:2016

Health software, Part 1: General requirements for product safety

SME reviewer

AAMI TIR80002-3:2016

Medical device software, Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Certifications

  • ASQ Certified Software Quality Engineer (CSQE)Certification from ASQ, the American Society for Quality
  • Lead Auditor: ISO 13485, ISO 9001, AS9100DQuality management systems: ISO 13485 for medical devices, ISO 9001 for any industry, AS9100D for aerospace
  • Lean Six Sigma Black BeltProcess improvement and data-driven problem solving
  • Certified ScrumMasterAgile (Scrum) team facilitation, from Scrum Alliance

Professional service

  • Past Vice Chair, Technology, ASQ Software DivisionAmerican Society for Quality
  • Past Chair, IEEE Computer Society Chicago ChapterInstitute of Electrical and Electronics Engineers
  • ANSI Associate · IEC subject-matter expertAmerican National Standards Institute · International Electrotechnical Commission
  • Member of ASQ, IEEE and INCOSEAmerican Society for Quality · Institute of Electrical and Electronics Engineers · International Council on Systems Engineering

Where I've done the work

Software quality, design assurance and regulatory compliance roles at global medical technology and pharmaceutical companies, nutraceutical manufacturers working to pharmaceutical cGMPs, contract manufacturers and neuromodulation and device startups. Client and employer names stay confidential; I'm happy to talk through relevant experience on a call.

Education: M.S. in Information Technology (Information Security) and B.S. in Software Systems Engineering.

Book a 30-minute callRead the standards guidesDownload my CV (PDF)

You're in

Thanks, you're in. Check your inbox.

Cookies on this site

Essential storage keeps the site working and remembers this choice. With your OK, I'd also use HubSpot to see which articles and tools are useful, and to show my booking calendar on the contact page. Nothing optional loads until you choose, and you can change your mind anytime from Cookie settings at the bottom of every page.

What each option does
Accept all
Essential storage, the HubSpot booking calendar, and HubSpot analytics cookies.
Essential only
Essential storage and the HubSpot booking calendar, which sets its own cookies when it loads on the contact page. No analytics.
Deny
Only what's needed to remember this choice. No analytics, and the booking calendar stays off until you click to load it.

Privacy policy: cookies and analytics