- 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
- 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
- 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
- $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
- Annual Bonus Opportunity + Ceribell Equity
- 100% Employer paid Health Benefits for the Employee
- 50% - 70% Employer paid Health, Dental & Vision for dependents (according to plan selection)
- 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
- Joining a mission-minded organization
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Manufacturing Engineer - Sunnyvale, United States - Ceribell, Inc
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 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
In addition to your base compensation, Ceribell offers the following:
$100,000-$115,000 USD
