Ceribell

Ceribell

Staff Supplier Industrialization Engineer

Sunnyvale, CA · Staff+

Sponsorship not specified$142k-$169kDetected 4 days ago
Supply ChainVendor ManagementProcurementGD&TFDA RegulatoryMedical DevicesLeadershipCommunicationCollaboration

About the role

  • Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions.
  • Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!
  • We are hiring a Senior Supplier Industrialization Engineer to serve as the critical technical bridge between our US-based R&D teams and our global vendor and contract manufacturing (CM) network.

Responsibilities

  • Component Vendor Management: Maintain technical rigor across our diverse vendor base, including plastics, metals, PCBs, and optics. Qualify production processes and audit controls to ensure superior component-level yields and quality standards.
  • Engineering Change Oversight: Manage the evaluation and risk assessment of ECOs and DCOs. Ensure international vendors implement changes without disrupting the continuity of our global supply chain.
  • Sourcing Partnership: Collaborate with procurement teams to finalize vendor selections. While procurement handles commercial terms, you lead the technical workflow to ensure vendor capabilities meet our rigorous standards.
  • Vendor Qualification: Direct the formal qualification of new CMs per FDA 21 CFR 820.50 and ISO 13485. Oversee First Article Inspections and maintain the approved supplier list and related documentation.
  • Process Ownership: Maintain technical oversight of manufacturing processes post-launch. Analyze the impact of engineering changes on cost and capacity while driving continuous yield improvements.
  • Capacity Modeling: Develop and maintain detailed capacity models, including cycle times and station utilization. Proactively identify and mitigate bottlenecks to support production ramp-up.
  • High-Volume Scaling: Optimize the transition to high-volume production. Plan for tooling redundancy and process robustness across the global vendor network to ensure long-term scalability.
  • Automation Upgrades: Identify opportunities for automation on foreign production floors. Qualify semi-automated systems to eliminate bottlenecks and support high-volume manufacturing requirements.
  • Should-Cost Modeling: Create and maintain should-cost models for major sub-assemblies. Use data to anchor vendor negotiations and inform critical make-vs-buy decisions.
  • Cost Reduction Initiatives: Identify and execute cost-down programs through process and design optimizations. Partner with sourcing to implement reductions without sacrificing quality or regulatory compliance.

Requirements

  • Global Vendor Expertise: At least 3 years of direct oversight managing international contract manufacturers and component vendors.
  • Manufacturing Depth: Deep operational knowledge of global CMs.
  • High proficiency in mechanical assembly (GD&T, plastics, metals), PCBA quality (SMT, IPC-A-610), test engineering (ICT/FCT, Gauge R&R), and process validation.
  • Linguistic Fluency: Advanced proficiency in Mandarin is highly advantageous to effectively support our existing international manufacturing operations.
  • Deep operational knowledge of global CMs.
  • Advanced proficiency in Mandarin is highly advantageous to effectively support our existing international manufacturing operations.

Nice to have

  • B.S. in Mechanical, Electrical, Manufacturing, Mechatronics, or Biomedical Engineering
  • M.S. is highly preferred.
  • Academic Foundation: B.S. in Mechanical, Electrical, Manufacturing, Mechatronics, or Biomedical Engineering

Compensation

  • A candidate's final salary offer will be based on their skills, education, work location and experience, and thus it may diff
  • $142,000 - $169,000 USD
  • Compensation Range

Benefits

  • Remotely evaluate and approve factory-level engineering plans, process controls, and test coverage across sites in the US, China, and Vietnam.
  • International NPI & Transfer: Collaborate with R&D to drive the transition of precision medical devices from domestic design centers to global production lines.

Company info

  • About Ceribell
  • The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country.
  • Oversee company-owned tooling and gauges at CM sites.
  • Ensure all assets are properly qualified, maintained, and subject to strict revision control.
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