Senior Manufacturing Engineer, CMO Support - Pleasanton, CA

$137,000 - $150,000/Yr

Calyxo - Pleasanton, CA

Full-time - Mid Level

Pleasanton, CA

Miscellaneous Manufacturing

About the position

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, founded in 2016 to improve kidney stone treatment. The Manufacturing Engineer will support transfer and sustaining manufacturing activities at our Contract Manufacturing Organization (CMO) in Costa Rica and Mexico. This role involves working cross-functionally and with suppliers to ensure successful scaling and sustained success of medical device manufacturing processes. The engineer will identify and implement process improvements to enhance product quality, manufacturability, and production throughput.

Responsibilities

• Initiate, own, and complete technical projects leading to new/improved processes for CVAC 2.0.
• Work closely 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.
• Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while promoting product quality, process efficiency, and operator safety.
• Provide sustaining production line support including 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.

Requirements

• Bachelor of Science in Engineering or a combination of relevant education and experience
• Minimum 5 years' experience supporting medical device manufacturing at a CMO
• Experience in leading 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
• Compliance with relevant county, state, and Federal rules regarding vaccinations

Nice-to-haves

• Experience with electronic components/assembly in the context of medical device capital equipment
• Experience designing, building, and implementing manufacturing fixtures and processing aids
• Bilingual/proficiency in Spanish
• Knowledge of Spanish including the ability to communicate technical concepts

Benefits

• Competitive base salary range of $137,000 - $150,000
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation