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 designed to address unmet needs in the acute care setting, used in hundreds of community hospitals, large academic facilities, and major IDNs across the country. Our team is committed to transforming critical care through rapid seizure detection technology.

About the role

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 senior individual contributor role, you will own the technical vendor relationship to ensure our international supply chain is scalable, optimized, and technically credible. You will lead NPI industrialization, evaluate engineering solutions across global manufacturing sites, manage post-launch processes and capacity, conduct should-cost analyses, and qualify automation systems.

Responsibilities

• Technical Leadership Across Global Vendors
  • Global CM Management: Function as the primary technical authority for international contract manufacturing and component vendors. 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 vendors for plastics, metals, PCBs, and optics. Qualify production processes and audit controls to ensure high component-level yields and quality standards.
  • International NPI & Transfer: Collaborate with R&D to transition precision medical devices from domestic design centers to global production lines. Manage technical complexities of overseas design transfers in compliance with 21 CFR 820.30.
  • Operational Alignment: Drive vendor accountability across time zones and cultures. Perform 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 assets are qualified, maintained, and subject to strict revision control.
  • Engineering Change Oversight: Manage evaluation and risk assessment of ECOs and DCOs. Ensure international vendors implement changes without disrupting global supply chain continuity.
• Technical Sourcing & RFP Management
  • Technical RFP Management: Lead technical evaluation of vendor RFPs. Define scope of work, assess vendor capabilities, and provide formal recommendations following on-site audits.
  • Sourcing Partnership: Collaborate with procurement to finalize vendor selections, ensuring technical capabilities meet rigorous standards.
  • Vendor Qualification: Direct formal qualification of new CMs per FDA 21 CFR 820.50 and ISO 13485. Oversee First Article Inspections and maintain approved supplier documentation.
• Production Process, Capacity & Cost Ownership
  • Process Ownership: Maintain technical oversight of manufacturing processes post-launch. Analyze impact of engineering changes on cost and capacity while driving yield improvements.
  • Capacity Modeling: Develop and maintain detailed capacity models, including cycle times and station utilization. Proactively identify and mitigate bottlenecks.
  • High-Volume Scaling: Optimize transition to high-volume production. Plan for tooling redundancy and process robustness across the global vendor network.
  • Automation Upgrades: Identify opportunities for automation on foreign production floors. Qualify semi-automated systems to eliminate bottlenecks.
  • Should-Cost Modeling: Create and maintain should-cost models for major sub-assemblies. Use data to anchor vendor negotiations and inform make-vs-buy decisions.
  • Cost Reduction Initiatives: Identify and execute cost-down programs through process and design optimizations without sacrificing quality or compliance.
• Compliance, Validation & Supply Chain Risk
  • Validation & PPAP Leadership: Serve as supply chain technical lead for validation lifecycle. Manage IQ/OQ/PQ protocols and Supplier PPAP framework, including PFMEAs and control plans.
  • Sub-Tier Traceability: Own technical risk across sub-tier component network. Ensure vendors maintain rigid traceability and change-control protocols.
  • Material Review Board (MRB): Lead technical investigations for MRB. Partner with Quality to conduct root-cause analysis (8D/5-Why) at overseas sites.
  • Audit Readiness: Support Quality and Regulatory teams during formal inspections. Defend supplier controls, design transfer deliverables, and documentation for FDA, ISO, and MDR audits.
• Test Engineering & Process Quality Control
  • Functional Test Optimization: Collaborate with R&D to specify and improve functional test stations. Audit optical alignment rigs and touchscreen validation processes.
  • PCBA Process Quality: Drive PCBA process excellence at CM sites. Oversee reflow profiles, AOI/X-ray inspection standards, and IPC-A-610 compliance.
  • Equipment Qualification: Execute IQ/OQ/PQ on new manufacturing and test equipment at vendor sites. Set Gauge R&R requirements and perform capability studies.
• Collaboration & Stakeholder Influence
  • Design for Excellence (DFX): Represent Supply Chain in R&D reviews. Provide DFM/DFA/DFS feedback to address Quality, cost, capacity, and delivery constraints early in design.
  • Cross-Functional Partnership: Build 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.

Requirements

• Academic Foundation: B.S. in Mechanical, Electrical, Manufacturing, Mechatronics, or Biomedical Engineering; M.S. preferred.
• Experience: Over 7 years 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 and cultures.
• NPI Strategy & Execution: Proven experience navigating electromechanical products 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: Track record of leveraging DFM, yield, and cost analytics to drive tangible R&D design modifications.
• Operational & Cost Ownership: Full accountability for manufacturing processes, capacity modeling, and should-cost analysis for a product line, including leadership of cost-down initiatives and capacity expansion.
• Technical Sourcing Mastery: Ability to independently lead technical RFPs from specification and capability audits to final recommendations.
• Manufacturing Depth: 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 frameworks including PPAP, PFMEA, IQ/OQ/PQ, and Cpk/Ppk.
• Business Acumen: Fluent in commercial aspects of manufacturing, including MSAs, dual-sourcing strategies, supply chain risk mitigation, and cost structure trade-offs.
• Leadership & Communication: Superior interpersonal skills to maintain technical rigor with 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.

Benefits

• Performance-based incentive compensation
• Equity opportunities
• 100% employer-paid health benefits for employees
• 50% - 70% employer-paid health, dental, and vision for dependents (depending on plan selection)
• 100% paid life and long-term disability insurance
• 401(k) with a generous company match
• Employee Stock Purchase Plan (ESPP) with a discount
• Monthly cell phone stipend
• Flexible paid time off
• 13 paid holidays + 3 company wellness days
• Excellent parental leave policy
• Fantastic culture with career advancement opportunities
• Mission-driven organization

Pay

Compensation range: $142,000—$169,000 USD. Final salary offer will be based on skills, education, work location, and experience. Compensation may also include bonuses consistent with Ceribell’s corporate compensation plan.