Staff Supplier Industrialization Engineer

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!

• 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 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.

• 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.

• 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 MRB. Partner with Quality to conduct root-cause analysis (8D/5-Why) at overseas sites and define robust rework procedures.
• Audit Readiness: Support Quality and Regulatory teams during formal inspections. Defend supplier controls, design transfer deliverables, and documentation for FDA, ISO, and MDR audits.

• Functional Test Optimization: Collaborate with R&D to specify and improve functional test stations. Audit optical alignment rigs and touchscreen validation processes while optimizing station throughput.
• PCBA Process Quality: Collaborate with R&D to drive PCBA process excellence at CM sites. Oversee reflow profiles, AOI/X-ray inspection standards, and IPC-A-610 compliance to ensure high-quality electronics manufacturing.
• Equipment Qualification: Execute IQ/OQ/PQ on new manufacturing and test equipment at vendor sites. Set Gauge R&R requirements and perform capability studies to ensure station reliability.

• Design for Excellence (DFX): Represent Supply Chain in R&D reviews. Provide critical DFM/DFA/DFS feedback on technical aspects that can cause Quality, cost, capacity & delivery constraints early in the design phase.
• Cross-Functional Partnership: Build strong alliances across R&D, Quality, and Finance to ensure unified execution of supply chain objectives.
• Executive Reporting: Translate manufacturing and cost data into actionable insights for leadership. Support margin planning and present technical updates during operations reviews.
• Other responsibilities as assigned by your Manager/Supervisor

• Academic Foundation: B.S. in Mechanical, Electrical, Manufacturing, Mechatronics, or Biomedical Engineering; M.S. is highly preferred.
• Experience: Over 7 years of engineering experience in Supplier, Manufacturing, or Industrialization roles, with a focus on highly regulated and complex electromechanical systems such as medical devices or surgical robotics.
• Global Vendor Expertise: At least 3 years of direct oversight managing international contract manufacturers and component vendors. Demonstrated success in steering technical teams across diverse time zones, cultures, and operational landscapes.
• NPI Strategy & Execution: Proven experience in navigating at least one electromechanical product through the entire NPI lifecycle—from EVT through PVT—into stabilized high-volume production with measurable gains in yield, capacity, and cost efficiency.
• R&D Influence: A track record of leveraging DFM, yield, and cost analytics to drive tangible R&D design modifications; must demonstrate specific engineering changes successfully implemented.
• Operational & Cost Ownership: Full accountability for manufacturing processes, capacity modeling, and should-cost analysis for a product line, including personal leadership of cost-down initiatives and capacity expansion programs.
• Technical Sourcing Mastery: Ability to independently lead technical RFPs from initial specification and capability audits to final recommendations; serves as a technical peer to procurement leadership.
• 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.
• Regulatory & Quality Expertise: Comprehensive understanding of FDA 21 CFR 820 (Design Transfer and Supplier Controls), ISO 13485, and core frameworks including PPAP, PFMEA, IQ/OQ/PQ, and Cpk/Ppk.
• Business Acumen: Fluent in the commercial aspects of manufacturing, including MSAs, dual-sourcing strategies, supply chain risk mitigation, and cost structure trade-offs.
• Leadership & Communication: Superior interpersonal skills with the ability to maintain technical rigor when directing vendors, manage multifaceted tasks, and deliver data-centric insights to executive stakeholders.
• Global Mobility: Willingness to travel up to 30% to international and domestic manufacturing sites.
• Linguistic Fluency: Advanced proficiency in Mandarin is highly advantageous to effectively support our existing international manufacturing operations.