Director of Manufacturing Operations

An innovative consumer health technology company is looking for a Director of Medical Operations to lead manufacturing operations and design verification/validation for their medical products division — working closely with R&D, Clinical, QA/RA, and the executive team.

What you'll own:

🔹 Manufacturing controls and process implementation specific to medical-grade products — while maintaining operational velocity

🔹 Global (OUS) manufacturing oversight — hands-on partnership with international manufacturing partners across varying quality maturity levels

🔹 Design verification and validation testing efforts, in close collaboration with R&D and QA/RA

🔹 Risk management documentation guidance across cross-functional engineering teams

🔹 Bridging QA/RA and Engineering to accelerate medical product upgrades from the consumer platform

What you bring:

✅ 8+ years in operations or manufacturing for medical devices, ideally with a background spanning both medical-grade and consumer product environments

✅ Track record supporting successful FDA clearances (510(k), De Novo)

✅ Experience managing and initiating global manufacturing initiatives (Asia, Mexico, etc.) — comfortable being hands-on when something breaks and needs a boots-on-the-ground fix

✅ Strong cross-functional program management across Engineering, QA/RA, and Manufacturing

✅ Bachelor's degree or equivalent experience