Supplier Engineering Manager (Sunnyvale)

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 Description:

Ceribell is seeking an experienced Manager, Supply Chain Engineering to lead our supplier engineering team. This role focuses on overseeing supplier qualification, engineering capability development, and ensuring suppliers meet stringent quality and compliance standards. The Manager, Supply Chain Engineering will be responsible for managing supplier relationships (technical), and driving continuous improvement initiatives to optimize manufacturing processes.

This position requires a proven track record in supplier management, team leadership, compliance with FDA and ISO standards, and collaboration with cross-functional teams, including Quality, Product Design, R&D, and Operations. This is a key leadership role in ensuring that our supply chain delivers high-quality, reliable, and cost-effective components for our products.

Responsibilities:

Supplier Qualification and Management:

• Oversee the supplier qualification process, ensuring new and existing suppliers meet engineering, quality, and production standards.
• Conduct and lead on-site audits at overseas supplier locations to evaluate manufacturing capabilities, compliance with FDA (21 CFR Part 820) and ISO 13485 standards, and overall quality systems.
• Develop and implement robust qualification strategies, including process capability studies, First Article Inspections (FAI), and Production Part Approval Process (PPAP).

Technical Assessment and Support:

• Lead technical reviews to assess supplier engineering capabilities, including tooling design, automation systems, and high-volume manufacturing readiness.
• Provide guidance to suppliers in resolving quality and process issues, emphasizing continuous improvement and process optimization.
• Identify and drive opportunities for automation and process enhancements at supplier facilities.
• Support the successful introduction of new products by ensuring suppliers are prepared for production at required quality and capacity levels.
• Work closely with R&D and Product Design teams to ensure supplier capabilities align with new product requirements.
• Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) discussions to optimize supplier processes for NPI.
• Oversee supplier validation and qualification activities for new product launches, ensuring seamless transitions from development to production.
• Establish scalable supplier processes to support volume ramp-up and long-term manufacturing success.

Cross-Functional Collaboration:

• Partner with Quality, Product Design, R&D, and Operations teams to align supplier capabilities with product specifications and regulatory requirements.
• Lead cross-functional Design for Manufacturability (DFM) reviews to ensure supplier processes can meet product design requirements at scale.
• Act as a key liaison between suppliers and internal teams to resolve engineering and production challenges.

Process Improvement and Compliance:

• Drive supplier process improvement initiatives focused on automation, defect reduction, and efficiency gains.
• Establish and monitor Key Performance Indicators (KPIs) such as defect rates, on-time delivery, and yield rates, implementing corrective actions as needed.
• Ensure suppliers comply with GMP, FDA, ISO 13485, and ISO 9001 requirements through strong auditing and qualification processes.

Risk Management and Strategic Sourcing:

• Conduct risk assessments and implement mitigation strategies to address potential supply chain disruptions.
• Lead efforts to qualify second-source suppliers to reduce risks and improve supply chain resilience.
• Collaborate with Procurement to drive cost reduction initiatives through process optimization and supplier negotiations.

Documentation and Reporting:

• Maintain comprehensive supplier qualification documentation, audit reports, and corrective action plans.
• Provide regular reports on supplier performance, risks, and improvement initiatives to senior management.
• Ensure accurate and timely documentation of non-conformance reports (NCRs), corrective actions (CAPA), and other compliance-related activities.

Team Leadership and Management:

• Lead, mentor, and develop a team of supplier engineers, fostering a culture of technical excellence and continuous improvement.
• Establish team goals, provide performance feedback, and support career development of team members.
• Coordinate cross-functional initiatives to enhance supplier qualification and process optimization.

Requirements/Qualifications

Education:

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field.

Experience:

• 7+ years of experience in supplier qualification, manufacturing engineering, or process engineering in the medical device industry.
• 2+ years of experience in leading and managing teams in supply chain or engineering roles.
• Proven track record of managing overseas suppliers and supporting high-volume production.
• Strong knowledge of FDA (21 CFR Part 820), ISO 13485, and ISO 9001 requirements for medical devices.
• Experience in qualifying suppliers for molding, automation, and process improvements.
• Experience supporting New Product Introduction (NPI) and scaling supplier processes for mass production.

Skills:

• Strong leadership and people management skills, with the ability to mentor and develop high-performing teams.
• Proficiency in quality tools such as FMEA, SPC, 8D, and Root Cause Analysis.
• In-depth understanding of automation systems and process improvement methodologies.
• Excellent problem-solving, analytical, and project management skills.
• Effective communication and relationship management skills, particularly with overseas suppliers.

Willingness to Travel:

• Up to 20% domestic or international travel to supplier locations as required.