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Manufacturing Engineer

4 months ago

Sunnyvale, United States Ceribell, Inc Full time

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 #LI-BD1

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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* -- For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. 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. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. 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. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Voluntary Self-Identification of Disability

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For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. 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. Gender

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If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. 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. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status

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