Staff Supplier Industrialization Engineer

About this role

About Ceribell

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. 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. 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!

Position Overview :

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. 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. 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. In this role, you will be the absolute technical owner of the vendor relationship to ensure our international supply chain is technically credible, highly scalable, and fiercely optimized.

This is a senior individual contributor role for an engineer who has spent serious time operating within the global electromechanical manufacturing ecosystem and has a proven track record of managing overseas vendors. You will lead NPI industrialization, evaluate and approve engineering solutions across our global vendor manufacturing sites, vendor manufacturing process and capacity post-launch, conduct robust should-cost analyses, and qualify automation systems to scale capacity.

What you'll do:

Technical Leadership Across Global Vendors

• Global CM Management: Function as the primary technical authority for our international contract manufacturing and component vendor network. Remotely evaluate and approve factory-level engineering plans, process controls, and test coverage across sites in the US, China, and Vietnam.

• 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.

• International NPI & Transfer: Collaborate with R&D to drive the transition of precision medical devices from domestic design centers to global production lines. Manage the technical complexities of overseas design transfers in compliance with 21 CFR 820.30.

• Operational Alignment: Drive vendor accountability across various time zones and cultures. Perform comprehensive technical audits and line balance assessments on-site during critical launch milestones.

• Tooling & Fixture Control: Oversee company-owned tooling and gauges at CM sites. Ensure all assets are properly qualified, maintained, and subject to strict revision control.

• 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.

Technical Sourcing & RFP Management

• Technical RFP Management: Lead the technical evaluation of vendor RFPs. Define scope of work requirements, assess vendor capabilities, and provide formal recommendations following on-site technical audits.

• 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.

Production Process, Capacity & Cost Ownership

• 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.

Compliance, Validation & Supply Chain Risk

• Validation & PPAP Leadership: Serve as the supply chain technical lead for the validation lifecycle. Manage IQ/OQ/PQ protocols and the Supplier PPAP framework, including PFMEAs and control plans, across global sites.

• Sub-Tier Traceability: Take ownership of technical risk across the sub-tier component network. Ensure international vendors maintain rigid traceability and follow change-control protocols to mitigate supply risks.

• Material Review Board (MRB): Lead technical investigations for the

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