Manufacturing Engineer

Research & Development           ·          Sunnyvale, CA         ·         Full time

About Ceribell

Ceribell produces the world’s first brain monitor for point-of-care seizure triage and treatment. Our groundbreaking technology enables healthcare providers to test for a suspected seizure and then deliver treatments within minutes. We also received the first-ever FDA 510(k) clearance for a digital seizure detection algorithm.

We are a rapidly growing venture capital-backed medical technology startup. Ceribell is being used in hundreds of community hospitals, large academic facilities and major IDN’s across the country. With extensive clinical validation of the effectiveness of our product and significant growth potential, all while we are pre-IPO, Ceribell is a fantastic career opportunity.

Position Overview

Participates in development and manufacturing related to Ceribell products. Sustains existing manufacturing processes and also supports the development and introduction of new designs and improvements. Participates in risk management activities. Works with external vendors and contractors. This role will require some leadership and project management skills and could evolve into a management role for a group of engineers.

What You’ll Do

• Work in a multi-disciplinary, cross-functional team to support rapid production growth while maintaining product quality
• Work with R&D team in manufacturing transfer and pilot manufacturing activities
• Work with Supply Chain team to support component and vendor qualification, including defining requirements, tests and fixtures
• Support initiatives for manufacturing automation and supply chain risk mitigation
• Work with Quality team to review and develop appropriate verification, validation, and qualification criteria for vendors and contract manufacturers, including machine and process specifications, process flow charts, IQ’s, OQ’s, PQ’s, and FMEA’s
• Conduct and review failure mode analyses on product manufacturing and root cause analyses on field or assembly failures
• Participate in risk management activities
• Collaborate closely with internal and external resources
• Provide internal and external product support as needed

What You’ll Need

• Bachelor’s Degree or higher in Science or Engineering
• Experience with medical device manufacturing
• Experience with manufacturing and assembly process development
• Experience with mechanical design and CAD tools
• Experience planning and managing projects and timelines beyond individual, day-to-day tasks
• Experience with high-volume or automated manufacturing
• Working experience with Solidworks
• Aptitude to learn and incorporate new technologies
• Excellent critical analysis and reasoning skills
• Strong writing, oral communication, and presentation skills with experience communicating effectively with management
• Flexible to effectively execute multiple projects and priorities simultaneously

Other Preferred Qualifications

• 7+ years relevant experience in medical device/healthcare manufacturing
• Experience with high-volume manufacturing
• Experience with semi-automated / automated manufacturing
• Experience in utilizing statistical analysis tools to develop insights into machine performance and process capability
• Ability and desire to work in a fast-paced team environment with an entrepreneurial spirit

What We Offer

• $130-135K + Bonus Opportunity +  Ceribell Equity 
• 100% Employer paid Health Benefits for the Employee 
• Life & Long-term disability insurance paid 100% by Ceribell
• Flexible paid time off
• 11 Paid Holidays
• Maternity and Paternity Leave 
• Fantastic culture with tremendous career advancement opportunities

Please click here to apply.