Production Supervisor Leader

1 week ago


Sunnyvale, California, United States Ceribell, Inc Full time
Job Summary

Ceribell, Inc. is a rapidly growing medical technology company that produces innovative brain monitors for point-of-care seizure triage and treatment. We are seeking a highly motivated Manufacturing Operations Manager to oversee production operations and ensure manufacturing processes run reliably and efficiently.

Key Responsibilities
  • Supervise daily production line operations while adhering to regulatory standards, including CFR 21 and ISO 13485.
  • Collaborate with the Production Planner for manufacturing schedule alignment and workflow optimization.
  • Perform work order transactions in the ERP system, ensuring accuracy and timely execution.
  • Address and resolve equipment malfunctions and production delays promptly.
  • Lead, train, and mentor manufacturing staff, promoting a continuous improvement culture.
  • Enforce safety guidelines and protocols to maintain a safe working environment.
  • Work with the Quality Assurance team to swiftly address quality concerns.
  • Participate in the Material Review Board (MRB) process, dealing with non-conforming materials and products.
  • Participate in the RMA process, dealing with return and refurbishment of products.
  • Collect and report data on product failure and root causes during production activities.
  • Stay up-to-date on industry best practices related to the production line.
  • Assist in managing and maintaining essential company assets for daily operations.
  • Monitor and report on production metrics, pinpointing areas for improvement.
Requirements
  • Bachelor's degree in Engineering, Manufacturing, Production Management, or equivalent experience.
  • 5+ years in medical device production, with a preference for experience with capital equipment and disposables.
  • 2+ years in a leadership or supervisory role.
  • Familiarity with MRB processes and NCR procedures.
  • Familiarity with ECO processes.
  • Experience in New Product Introductions (NPI).
  • Experience in Mastercontrol Mx is a plus.
  • Experience in Internal, ISO audit.
  • Experience in production planning and scaling.
  • Familiar with NetSuite ERP or similar systems.
  • Good understanding of regulatory standards such as CFR 21, ISO 13485, and GMP.
  • Proficient with basic applications (Excel, Word, Outlook) and Quality Management Systems (QMS), including associated software like Arena.
  • Strong communication, interpersonal, and problem-solving skills.
  • Ability to lead effectively and adapt in a fast-paced environment.
  • Familiarity with both semi and fully-automated medical device assembly technologies.
  • Proven ability to lead projects to successful completion.
  • Experience with electronics and electrical test equipment is a plus.
What We Offer
  • Annual Bonus Opportunity + Ceribell Equity
  • 100% Employer paid Health Benefits for the Employee
  • Life & Long-term disability insurance paid 100% by Ceribell
  • Monthly cell phone stipend
  • Flexible paid time off
  • 11 Paid Holidays
  • Excellent parental leave policy
  • Fantastic culture with tremendous career advancement opportunities

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