Director of Manufacturing Operations

Posted 15 days ago

biotalentSacramento (CA)
Industrial Production ManagersElectromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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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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