Manufacturing Engineer - Sunnyvale, United States - Ceribell, Inc

Ceribell, Inc Sunnyvale, United States

3 weeks ago

Description

About CeribellCeribell 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 OverviewParticipates 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 DoWork in a multi-disciplinary, cross-functional team to support rapid production growth while maintaining product qualityWork with Supply Chain to support component and vendor qualification, including defining requirements, tests and fixturesSupport initiatives for supply chain risk mitigation and increased production capacityWork 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'sConduct and review failure mode analyses on product manufacturing and root cause analyses on field or assembly failuresReview NCRs, including root cause analysis, risk assessment, containment, corrective actions, and final dispositionCreate Documentation Change Orders (DCOs) for sustaining manufacturing improvementsParticipate in risk management activitiesCollaborate closely with internal and external resourcesProvide internal and external product support as neededWhat You'll NeedBachelor's Degree or higher in Science or EngineeringExperience in an ISO 13485 medical device manufacturing environmentExperience with root cause analysis, corrective actions, and continuous improvementExperience with mechanical design and CAD toolsAptitude to learn and incorporate new technologiesExcellent 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 simultaneouslyOther Preferred Qualifications1-3 years relevant experience in medical device/healthcare manufacturingExperience with manufacturing fixture designExperience with high-volume manufacturingExperience in utilizing statistical analysis tools like Minitab to develop insights into process capability and product qualityExperience with semi-automated / automated manufacturingAbility and desire to work in a fast-paced team environment with an entrepreneurial spiritWhat We Offer$100-115K + Bonus Opportunity + Ceribell Equity 100% Employer paid Health Benefits for the Employee Life & Long-term disability insurance paid 100% by CeribellFlexible paid time off11 Paid HolidaysMaternity and Paternity Leave Fantastic culture with tremendous career advancement opportunities#LI-BD1In addition to your base compensation, Ceribell offers the following:Annual Bonus Opportunity + Ceribell Equity 100% Employer paid Health Benefits for the Employee50% - 70% Employer paid Health, Dental & Vision for dependents (according to plan selection)Life & Long-term disability insurance paid 100% by CeribellMonthly cell phone stipendFlexible paid time off11 Paid HolidaysExcellent parental leave policyFantastic culture with tremendous career advancement opportunitiesJoining a mission-minded organizationCompensation Range$100,000-$115,000 USD

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