Months
Productivity
Acceptance Rate
Built for Demanding Manufacturing Environments
Medical device manufacturing is a zero-defect environment, where the mandate is to move at the speed the market rewards while operating under the FDA’s QMSR (now harmonized with ISO 13485:2016), in which a single lapse can result in a recall, a warning letter, or patient harm.
The wrong executive doesn’t just underperform. They put your regulatory standing at risk. Most leaders are built to protect or to accelerate. We find the rare ones who do both. Conventional search screens for what a leader has done; we validate how they think, measuring cognitive fit against your specific compliance demands before a candidate ever reaches your desk.
Our Tijuana, Baja California, and broader Mexico medical device leadership network is unmatched. One of the world’s largest concentrations of medical device manufacturing sits on the US-Mexico border, and we have been operating there for over three decades. We don’t source into this region. We have lived in it.
We place medical device executives who accelerate launches, transfers, and scale while protecting quality, regulatory standing, and patient safety. Validated on judgment under pressure, not just credentials.
What We Solve in Medical Devices
FDA 483 & Warning Letter Recovery
Leaders who rebuild quality systems under regulatory pressure.
Clinical-to-Commercial Scale-Up
Executives who bridge development and full manufacturing.
Quality Under Volume Pressure
Maintaining zero-defect standards as production ramps.
Dual-Site US-Mexico Operations
Cross-cultural leadership in multilingual environments.
PE Portfolio Build-Out
Rapid leadership assembly within investor timelines.
Class II / III Device Complexity
Deep regulatory acumen for high-consequence environments.
Download the Medical Device Hiring Guide
Examples of Roles We Place
Our Mexico Network Is Your Competitive Advantage.
Tijuana and the Full Baja California Corridor. Ciudad Juarez and Chihuahua. Monterrey. All of Sonora. We have been building medical device talent networks here for 30+ years. National US search firms don’t have this access. We do—and it gives our clients first-mover advantage on the region’s best executive talent.