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EightsleepEightsleepSan Francisco, CA

Director of Medical Operations

Lead medical operations for sleep fitness medical devices at Eight Sleep. Implement manufacturing controls, oversee design verification/validation testing, FDA clearances, and risk management while collaborating with R&D, QA/RA, and clinical teams. Requires 8+ years medical device operations experience and successful FDA track record.

Salary not listed
On-site8+ YOEOther

About the role

How you’ll contribute

  • Implement mandated manufacturing controls while maintaining high velocity operational efficiency
  • Collaborate with R&D and RA/QA to execute critical testing initiatives
  • Guide cross-functional engineering teams in producing risk management documentation
  • Collaborate with the consumer operations leads to accelerate medical product upgrades
  • Contribute to ROI assessments for potential medical product adaptations (new markets)

What you need to succeed

  • 8+ years of industry experience in operations or manufacturing functions for medical devices
  • Successful track record of FDA clearance (510(k), De Novo)
  • Exemplary at cross-functional program management
  • Experience managing and initiating global manufacturing initiatives
  • Bachelor’s degree or equivalent experience

Compensation & Benefits

  • Competitive salary and equity
  • Full access to health, vision, and dental insurance for you and your dependents
  • Supplemental life insurance
  • Flexible PTO
  • Paid parental leave
  • Team offsite and company events
  • Employee discount on Eight Sleep products
  • Opportunity to work with a world-class team building category-defining technology
  • Your own Pod - and other great benefits

Skills

Medical DevicesFda Clearance510(K)De NovoManufacturing ControlsRisk ManagementCross-Functional Program ManagementGlobal Manufacturing

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