Senior Manufacturing Engineer

About the position

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.

Responsibilities

• 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

• 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

Nice-to-haves

• Experience with electronics and electrical test equipment
• Experience in new product introductions

Benefits

• 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