Director of Manufacturing Operations
Posted 15 days ago
biotalentSacramento (CA)
Industrial Production ManagersElectromedical and Electrotherapeutic Apparatus Manufacturing
SENIORITY
Manager
About the role
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 velocityGlobal (OUS) manufacturing oversight — hands-on partnership with international manufacturing partners across varying quality maturity levelsDesign verification and validation testing efforts, in close collaboration with R&D and QA/RARisk management documentation guidance across cross-functional engineering teamsBridging QA/RA and Engineering to accelerate medical product upgrades from the consumer platformWhat you bring:8+ years in operations or manufacturing for medical devices, ideally with a background spanning both medical-grade and consumer product environmentsTrack 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 fixStrong cross-functional program management across Engineering, QA/RA, and ManufacturingBachelor's degree or equivalent experience
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