Manufacturing Operations Manager

4 days ago

Sunnyvale, California, United States Ceribell, Inc Full time
About Ceribell, Inc.

Ceribell, Inc. is a rapidly growing medical technology startup that produces innovative brain monitors for point-of-care seizure triage and treatment. Our cutting-edge technology enables healthcare providers to test for a suspected seizure and deliver treatments within minutes.

Position Overview

Ceribell, Inc. is currently seeking a highly motivated Manufacturing Operations Manager to oversee production operations, ensuring manufacturing processes run reliably and efficiently. This position requires close collaboration with various teams, including Production Planning, Engineering, and Quality Assurance.

Key Responsibilities
  • Supervise daily production line operations while adhering to regulatory standards, such as 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.
  • Engage with Engineering, Logistics, and Inventory teams to refine processes and assist in developing assembly instructions, test methods, and reports for new product introductions.
  • Take ownership of the electronic Device History Record (eDHR) MasterControl MX platform to ensure data is up-to-date, accurate, and continuously improved.
Requirements and Qualifications
  • 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.
Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Individuals will be required to sit for the majority of the day and will be required to stand as needed. May require walking primarily on a level surface for periods of time throughout the day. The employee is occasionally required to stand, walk, climb or balance, stoop, kneel, crouch or crawl and talk or hear. Proper lifting techniques will be required to lift up to 50lbs. Individuals may be required to travel via airplane, train, taxi, car and/or other means of transportation as needed.

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