Senior Manufacturing Engineer

Ceribell │ Point-of-Care EEG; Sunnyvale (CA); On-site; USD 125,000 - 155,000; Full time

Job summary

Ceribell, a pioneering medical technology company, is seeking a Sr. Manufacturing Engineer to innovate and enhance processes for our advanced disposable devices and Recorder equipment. This role is crucial in monitoring production issues, improving quality processes, and working closely with suppliers across borders to ensure product excellence. Ideal candidates are seasoned professionals with a passion for transformative healthcare solutions, eager to contribute to rapid developments in critical care.

Benefits

Annual Bonus + Equity Opportunity

100% Employer paid Health Benefits for Employees

401(k) with a generous company match

Flexible paid time off

11 Paid Holidays + 5 Company Wellness Days

Excellent parental leave policy

Qualifications

• At least 7 years of related experience in medical device manufacturing.
• Experience with FDA and ISO Quality System Regulations.
• Ability to prioritize projects and tasks.

Responsibilities

• Monitor and troubleshoot issues with disposable device manufacturing.
• Develop assembly instructions and test methods.
• Support manufacturing in production issues and process validations.

Skills

Problem Solving

Data Analysis

Interpersonal Skills

Communication Skills

Education

BS in Mechanical/Test Engineering or equivalent

Tools

Minitab

Excel

Arena

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 Overview

Ceribell 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
• Collects and reports 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
• Manages and maintains company assets required to perform all necessary job functions
• Supports manufacturing in production issues, including documentation, assembly/test, component evaluation, and subassembly performance issues
• Maintains clean production workspaces while following good manufacturing practices.
• Follows all safety and quality system requirements
• Performs scheduled preventative maintenance, including calibrations, hardware or software upgrades, and verification of system specifications
• Improves manufacturing work instructions
• Performs NCR preliminary investigation and documentation for component failure
• Performs 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 Demands

The 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 [e-mail] to request reasonable accommodation.

In addition to your base compensation, Ceribell offers the following:

• Annual Bonus + Equity Opportunity
• 100% Employer paid Health Benefits for Employees
• 100% paid Life and Long-Term Disability Insurance
• 401(k) with a generous company match
• Employee Stock Purchase Plan (ESPP) with a discount
• Monthly cell phone stipend
• Flexible paid time off
• 11 Paid Holidays + 5 Company Wellness Days
• Excellent parental leave policy
• Fantastic culture with tremendous career advancement opportunities
• Joining a mission-minded organization!

Compensation Range

$125,000 - $155,000 USD

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