Manufacturing Engineer - Sunnyvale, United States - Ceribell, Inc

Description

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 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 manufacturing related to Ceribell products. Sustains existing manufacturing processes and also supports continuous improvements and the qualification of new component suppliers. Participates in risk management activities. Works with external vendors and contractors.
What You'll Do
Work in a multi-disciplinary, cross-functional team to support rapid production growth while maintaining product quality
Work with Supply Chain to support component and vendor qualification, including defining requirements, tests and fixtures
Support initiatives for supply chain risk mitigation and increased production capacity
Work with Quality 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
Review NCRs, including root cause analysis, risk assessment, containment, corrective actions, and final disposition
Create Documentation Change Orders (DCOs) for sustaining manufacturing improvements
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 in an ISO 13485 medical device manufacturing environment
Experience with root cause analysis, corrective actions, and continuous improvement
Experience with mechanical design and CAD tools
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
1-3 years relevant experience in medical device/healthcare manufacturing
Experience with manufacturing fixture design
Experience with high-volume manufacturing
Experience in utilizing statistical analysis tools like Minitab to develop insights into process capability and product quality
Experience with semi-automated / automated manufacturing
Ability and desire to work in a fast-paced team environment with an entrepreneurial spirit
What We Offer
$100-115K + 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
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In addition to your base compensation, Ceribell offers the following:
Annual Bonus Opportunity + Ceribell Equity
100% Employer paid Health Benefits for the Employee
Life & Long-term disability insurance paid 100% by Ceribell
Monthly cell phone stipend
Flexible paid time off
11 Paid Holidays
Excellent parental leave policy
Fantastic culture with tremendous career advancement opportunities
Does the listed salary meet your compensation requirements?



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As set forth in Ceribell, Inc's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

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