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 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.

HOW I WORK

Every engagement starts with the Medical Device Delivery Assessment — a five-dimension diagnostic that shows leadership exactly where the risk is before a single resource is reallocated. From there, we size a 90-Day Execution Partnership to what's actually needed: an Advisory, Implementation, or Embedded Executive track — the same three tracks whether the priority is project management or software validation. Underneath all three, the actual work runs on the IMPACT Blueprint™, my internal delivery framework (Investigate, Measure, Plan, Activate, Complete, Transfer) built from 25+ years leading complex, regulated programs. It's why the last step of any track is always a clean handoff, not an open-ended retainer.

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

  • 25+ years of experience leading complex programs

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.

“Every month a medical device misses its FDA filing, your competitor is taking your market share. I'm a fractional Project Management Executive who steps in, owns the submission timeline, and gets your program across the finish line — PMP-certified, 25+ years in medical devices and life sciences, and 16 straight client renewals that prove I deliver. You get executive-level project leadership, without the executive-level price tag — and my current client has renewed me 16 consecutive times because they simply won't let me go.”

If your FDA submission timeline is keeping you up at night — let's talk. It's a candid conversation to see if we're the right fit, not a sales pitch. Book a time Here