Staff Supplier Industrialization Engineer

3 hours, 18 minutes ago
Full-time
Senior
Operations
Ceribell

Ceribell

Ceribell provides a point-of-care EEG solution for quickly monitoring and treating hospital patients at risk for seizures, offering 24/7 continuous bedside monitoring with their Clarity system.

Health Care Providers & Services
51-250
Founded 2014
$220M raised

Description

  • Serve as the primary technical authority for international contract manufacturers and component vendors across the U.S., China, and Vietnam.
  • Evaluate and approve factory-level engineering plans, process controls, and test coverage at supplier sites.
  • Lead new product introduction and design transfer activities from domestic R&D into global production lines.
  • Oversee tooling, gauges, and revision control at contract manufacturing sites.
  • Review and manage engineering change orders and design change orders to protect supply continuity.
  • Lead technical vendor RFP evaluations, site audits, and supplier qualification activities.
  • Own production process oversight after launch, including yield improvement, cost impact analysis, and capacity modeling.
  • Identify and qualify automation opportunities and semi-automated systems to remove bottlenecks and support scale-up.
  • Lead validation, PPAP, IQ/OQ/PQ, and supplier control activities across global sites.
  • Partner with R&D, Quality, Procurement, Finance, and leadership on design for excellence, sourcing decisions, audits, and executive reporting.

Requirements

  • B.S. in Mechanical, Electrical, Manufacturing, Mechatronics, or Biomedical Engineering; M.S. is highly preferred.
  • 7+ years of engineering experience in supplier, manufacturing, or industrialization roles.
  • 3+ years of direct oversight of international contract manufacturers and component vendors.
  • Experience taking at least one electromechanical product through the full NPI lifecycle from EVT through PVT into high-volume production.
  • Demonstrated ability to drive R&D design changes using DFM, yield, and cost analytics.
  • Full ownership experience in manufacturing process management, capacity modeling, should-cost analysis, and cost-down initiatives.
  • Ability to independently lead technical RFPs from specification through final recommendation.
  • Deep knowledge of global contract manufacturing, mechanical assembly, PCBA quality, test engineering, and process validation.
  • Working knowledge of FDA 21 CFR 820, ISO 13485, PPAP, PFMEA, IQ/OQ/PQ, and Cpk/Ppk.
  • Understanding of MSAs, dual-sourcing strategies, supply chain risk mitigation, and manufacturing cost trade-offs.
  • Strong interpersonal and communication skills with the ability to influence vendors and present to executive stakeholders.
  • Willingness to travel up to 30% to domestic and international manufacturing sites.
  • Advanced proficiency in Mandarin is highly advantageous.

Benefits

  • Performance-based incentive compensation.
  • Equity opportunities.
  • 100% employer-paid health benefits for employees.
  • 50% to 70% employer-paid health, dental, and vision coverage 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 plus 3 company wellness days.
  • Excellent parental leave policy.

Interested in this position?

Apply directly on the company website

Apply Now

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