Manufacturing Engineer – Capital - Pleasanton, CA

About this role

Calyxo seeks a Manufacturing Engineer to develop and optimize manufacturing processes for their kidney stone treatment device (CVAC 2.0) in Pleasanton, CA. You'll work cross-functionally to design efficient, scalable production processes while supporting quality, regulatory compliance, and continuous improvement in a medical device environment.

What you'll do

• Lead technical projects to develop and improve manufacturing processes for CVAC 2.0 capital equipment
• Design manufacturing procedures, tooling, and fixtures that optimize quality, efficiency, and operator safety
• Provide sustaining production support including process improvements, equipment troubleshooting, and operator training
• Create and maintain manufacturing documentation while ensuring regulatory and procedural compliance
• Apply LEAN and Six Sigma methodologies for problem-solving and continuous improvement
• Support process and equipment validation (IQ/OQ/PQ) and generate technical drawings in SolidWorks

What they're looking for

• Manufacturing process design and optimization
• Medical device manufacturing and FDA/ISO regulatory knowledge (QSR, cGMP, ISO13485)
• SolidWorks CAD proficiency
• LEAN and Six Sigma methodologies
• Design Control and structured design processes (ISO9000)
• Cross-functional project leadership and communication
• Electronic component assembly experience
• Equipment validation and troubleshooting

Benefits

• Competitive base salary of $125,000–$135,000 plus variable incentive plan
• Stock options providing ownership stake in the company
• 401(k) retirement plan
• Healthcare insurance coverage
• Dynamic learning environment with experienced leadership team