Senior Manufacturing Engineer

Company: Tbwa Chiat/Day Inc
Location: Sunnyvale
Posted on: March 25, 2025

Job Description:

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!Position OverviewCeribell is currently seeking a Sr. Manufacturing Engineer. We are looking for a highly motivated individual who thrives in a fast-paced work environment. The Sr. Manufacturing Engineer supports developing and improving processes of the expanding line of disposable devices and innovative Recorder equipment. The primary responsibilities of this position will be monitoring and troubleshooting any issues with the disposable device line of products, improving manufacturing and quality processes, assembly instructions, and all necessary manufacturing documentation, including NPI and R&D projects. The ideal candidate should also be familiar with electro/mechanical medical device equipment. In addition, this position will support Manufacturing facilities outside of the US.Essential Job Functions

• Apply engineering principles and concepts to evaluate new designs for function, performance, and manufacturability.
• Utilize Engineering concepts or tools such as Design of Experiments and Minitab.
• Develop assembly instructions and test methods and create test and qualification reports for new product introduction.
• Identify and create process validations for manufacturing processes (IQ, OQ and PQ).
• Design or support outside design consultants for implementing medical device semi and fully-automated assembly technologies.
• Responsible for all issues on the disposable Headband and Recorder device manufacturing line including processing and resolving NCRs when appropriate.
• Collect and report on product failure/root-cause data collected during production activities to support current product improvement and future product development.
• Work with outside suppliers, contract manufacturers, and component suppliers to develop, qualify, release and introduce new systems/sub-systems and components into production including support of facilities outside of US.
• Initiate, execute & review product Engineering/Document Change Orders.
• Provide support for incoming component inspection, tracking of component issues, and supply chain team interfacing to assure product quality.
• Manage and maintain company assets required to perform all necessary job functions.
• Support manufacturing in production issues, including documentation, assembly/test, component evaluation, and subassembly performance issues.
• Maintain clean production workspaces while following good manufacturing practices.
• Follow all safety and quality system requirements.
• Perform scheduled preventative maintenance, including calibrations, hardware or software upgrades, and verification of system specifications.
• Improve manufacturing work instructions.
• Perform NCR preliminary investigation and documentation for component failure.
• Perform device assessment and rework for the returned Recorders.Requirements/Qualifications
  • BS in Mechanical/Test Engineering or equivalent experience with at least 7 years related work experience in medical device manufacturing and product development.
  • Strong knowledge of FDA and ISO Quality System Regulations.
  • Ability to identify, manage and implement product and process cost reductions to meet department and corporate goals.
  • Experience with yield enhancements, cycle time reduction, product cost reduction, process optimization, and data analysis.
  • Ability to solve practical problems and deal with various variables in situations where only limited standardization exists.
  • Must have strong interpersonal and written/verbal communication skills.
  • A self-starter who can prioritize projects and tasks, work with various personalities, and be comfortable with multi-tasking.
  • Ability to apply common sense understanding to complete written, oral, or diagram instructions.
  • Sufficient project management skills to track task status and complete assigned deliverables on schedule.
  • Experience with electronics and electrical test equipment is a plus.
  • Experience in new product introductions.
  • Strong computer and technology skills with software applications (Excel, Word, Outlook, PowerPoint), Arena, or similar Product Lifecycle Management Systems, and technology innovation.
  • Excellent teamwork skills and ability to work well with a multicultural workforce.
  • Travel to contract manufacturers/vendors that are located outside the US, 2-3 times per year.This job description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.Note: Candidates must be legally authorized to work in the United States.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.A candidate's final salary offer will be based on their skills, education, work location and experience, and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribell's corporate compensation plan. Note, the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status or any other characteristic protected by law. Any applicant with a disability who requires an accommodation during the application process should contact talent@ceribell.com to request reasonable accommodation.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.
    • Joining a mission-minded organization!Compensation Range$125,000 - $155,000 USDApply for this job
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Keywords: Tbwa Chiat/Day Inc, Sunnyvale , Senior Manufacturing Engineer, Engineering , Sunnyvale, California