Staff Manufacturing Engineer – CMO Support

Staff Manufacturing Engineer – CMO Support

Requirements

• Education: Bachelor of Science in Engineering or a combination of relevant education and experience
• Minimum 10 years’ progressive experience supporting medical device manufacturing at a CMO
• Work location: Pleasanton, CA
• Travel: up to 50%
• Full time employment
• Proven track record of leading and delivering highly technical projects in a cross functional environment
• Experience working in a structured design process such as ISO9000 or FDA QSR and knowledge of regulatory approval process and requirements
• Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001 and EN46001
• Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks

Responsibilities

• Lead and drive technical projects leading to new/improved processes for CVAC 2.0
• Partner cross-functionally with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability
• Oversee the design and development of manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety
• Provide sustaining production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries
• Train and support production personnel during transition of new products/processes to production
• Generate and modify high-quality manufacturing process documentation and assure that processes and documentation follow established policies and procedures
• Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement
• Assist in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment
• Generate and modify component/assembly/equipment drawings using Solidworks
• Write and execute process and equipment validations (IQ/OQ/PQ)
• Work with external vendors as needed
• Perform equipment maintenance by following manufacturer’s instructions and established procedures
• Effectively communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines
• Ensure product quality and support regulatory compliance

Preferred Qualifications

• Experience with electronic components/assembly in the context of medical device capital equipment
• Experience designing, building, and implementing manufacturing fixtures and processing aids
• Highly desirable: Bilingual/proficiency in Spanish