I'm the person medical device companies call when the FDA deadline is real and the stakes are high.

 

My current client has renewed my contract 16 consecutive times.

That's not a typo. Sixteen. At one of the world's leading medical device companies. My manager recently told me he's already looking at what he can do to bring me back again in January.

I don't share that to brag. I share it because when you're evaluating who to trust with your FDA submission timeline, your software validation program, or your most complex product development program — you deserve to know what kind of track record you're getting.

WHO I AM

I'm Curtis Griffy, founder of Problem Busters LLC and a PMP-certified Fractional Project Management Executive specializing in medical device software validation and FDA compliance programs.

Here's what makes me different from every other project manager you've talked to:

I've done the technical work.

I didn't start as a project manager. I started as an engineer — validating embedded software for infusion pumps and pacemakers at Boston Scientific, Medtronic, and Smiths Medical. I know the technical work from the ground up, which means I can challenge an engineer's assumptions, spot a gap in a validation package, and author documentation that holds up under FDA scrutiny — not just manage a Gantt chart.

I bring calm to chaos.

In high-pressure compliance situations, the emotional temperature in the room is high. Executives are nervous. Engineers are defensive. Regulatory teams are overwhelmed. Multiple colleagues at Smiths Medical and Abbott — independently and unprompted — used the same word to describe me: calm. In regulated environments, that's not a soft skill. That's what makes execution possible.

I own outcomes, not just tasks.

My clients don't extend me 16 times because I run good meetings. They extend me because I take their hardest problems off their plate — and I don't put them back until they're solved.

THE CREDENTIALS

  • MS Management — Project Management, Colorado Technical University

  • BS Electrical Engineering Technology, Purdue University

  • Project Management Professional (PMP)® #497326

  • Certified Scrum Master (CSM)® #468146

  • Six Sigma Green Belt

  • FDA 21 CFR 820 ·  IEC 62304  ·  ISO 13485  ·  ISO 14971

THE NUMBERS THAT MATTER

  • 40+ software systems validated across international sites (U.S., Japan, India, Korea, Canada, Europe)

  • $4.4M in programs delivered on time and within budget

  • 50% reduction in validation effort through streamlined risk classification

  • $1M+ saved in testing costs through automation

  • Zero FDA warning letters on my watch

  • 16 consecutive contract renewals at one of the world's leading medical device companies

WHAT DRIVES ME

I operate my business to honor Jesus Christ. One of the ways that shows up practically is giving a portion of every engagement to Feed My Starving Children — an organization I've packed meals with for years. My wife and I also sponsor two children through Compassion International.

I've led volunteer cleanup crews for the Minnesota DNR for years, and for 17 years I organized a volunteer event at the John Denver Sanctuary in Aspen, Colorado. Leadership and service are the same thing to me.

When I'm not working, you'll find me hiking, snowshoeing, gardening, or canning a batch of fire sauce and spaghetti sauce. And lately — learning everything I can about AI and how it can create new value for the programs I lead.

If you're looking for someone who will dig into the details, think strategically about where the value is, and drive your project to a meaningful finish—let's talk.

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