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Manufacturing Operations Manager

2 months 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 suspected seizures and deliver treatments within minutes.

Position Overview

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

Essential Job Functions
  • Supervise Daily Production Line Operations: Ensure manufacturing processes adhere to regulatory standards, such as CFR 21 and ISO.
  • Collaborate with Production Planner: Align manufacturing schedules and optimize workflow to meet production demands.
  • Perform Work Order Transactions: Execute work orders accurately and timely in the ERP system.
  • Address Equipment Malfunctions and Production Delays: Resolve issues promptly to minimize downtime and ensure production continuity.
  • Lead, Train, and Mentor Manufacturing Staff: Foster a continuous improvement culture and promote employee growth and development.
  • Enforce Safety Guidelines and Protocols: Maintain a safe working environment and ensure compliance with regulatory standards.
  • Work with Quality Assurance Team: Address quality concerns and implement corrective actions to ensure product quality.
  • Participate in Material Review Board (MRB) and Return Merchandise Authorization (RMA) Processes: Deal with non-conforming materials and products, and facilitate the return and refurbishment of products.
  • Collect and Report Data on Product Failure and Root Causes: Analyze data to identify areas for improvement and implement corrective actions.
  • Stay Up-to-Date with Industry Best Practices: Continuously update knowledge on production line technologies and best practices.
  • Assist in Managing and Maintaining Essential Company Assets: Ensure daily operations run smoothly and efficiently.
  • Monitor and Report on Production Metrics: Identify areas for improvement and implement corrective actions to optimize production efficiency.
  • Engage with Engineering, Logistics, and Inventory Teams: Refine processes and assist in developing assembly instructions, test methods, and reports for new product introductions.
  • Take Ownership of Electronic Device History Record (eDHR) MasterControl MX Platform: Ensure data is up-to-date, accurate, and continuously improved.
  • Support New Equipment Integration and Qualification Processes: Collaborate with engineers to ensure compliance with validation protocols.
Requirements/Qualifications
  • Bachelor's Degree in Engineering, Manufacturing, Production Management, or Equivalent Experience: A degree in a relevant field or equivalent experience is required.
  • 5+ Years in Medical Device Production: Experience in medical device production, preferably with capital equipment and disposables.
  • 2+ Years in Leadership or Supervisory Role: Proven leadership or supervisory experience is required.
  • Familiarity with MRB Processes and NCR Procedures: Knowledge of material review board processes and non-conformance report procedures is essential.
  • Familiarity with ECO Processes: Experience with engineering change order processes is required.
  • Experience in New Product Introductions (NPI): Experience in new product introductions is highly desirable.
  • Experience in MasterControl MX: Familiarity with MasterControl MX is a plus.
  • Experience in Internal, ISO Audit: Experience in internal audits, preferably ISO audits, is required.
  • Experience in Production Planning and Scaling: Knowledge of production planning and scaling is essential.
  • Familiarity with NetSuite ERP or Similar Systems: Experience with NetSuite ERP or similar systems is required.
  • Good Understanding of Regulatory Standards: A good understanding of regulatory standards, such as CFR 21, ISO 13485, and GMP, is essential.
  • Proficient with Basic Applications and Quality Management Systems: Proficiency in basic applications, such as Excel, Word, and Outlook, and quality management systems, including associated software like Arena, is required.
  • Strong Communication, Interpersonal, and Problem-Solving Skills: Excellent communication, interpersonal, and problem-solving skills are essential.
  • Ability to Lead Effectively and Adapt in a Fast-Paced Environment: The ability to lead effectively and adapt in a fast-paced environment is required.
  • Familiarity with Semi and Fully-Automated Medical Device Assembly Technologies: Familiarity with both semi and fully-automated medical device assembly technologies is a plus.
  • Proven Ability to Lead Projects to Successful Completion: Proven ability to lead projects to successful completion is essential.
  • Experience with Electronics and Electrical Test Equipment: 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.