Sr. Manufacturing Specialist

Position Overview 

Ceribell is currently seeking a Sr. Manufacturing Specialist. We are looking for a highly motivated individual who  thrives in a fast-paced work environment. The Sr. Manufacturing Specialist supports developing and producing  its 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. 

Essential Job Functions 

• Develop assembly instructions and test methods and assist with creating test and qualification  reports 
• Identify and create process validations for manufacturing processes (IQ, OQ and PQ)
• 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 
• Assist with initiating, reviewing and executing 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 

• Experience in Mechanical/Test Engineering with at least 8 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 
• Familiar with medical device semi and fully-automated assembly technologies
• Experience with yield enhancements, cycle time reduction, product cost reduction, process  optimization, and data analysis 
• 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 
• 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. 

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.

 What we offer: 

• Base + bonus + equity
• 100% Employer Paid Health, Dental and Vision for the Employee
• 50%- 70% Employer Paid Heath, Dental and Vision for dependents (according to plan selection) 
• Ceribell Equity
• A flexible vacation policy and 11 paid holidays 
• Monthly Cell Phone Reimbursement  
• Flex spending account, life insurance, and disability insurance
• Excellent parental leave policy
• Joining a mission minded organization!