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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