Senior Mechanical Design Engineer – Medical Devices & NPD

Intuitive (Intuitive Surgical); Sunnyvale (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Intuitive in Sunnyvale, CA seeks a Senior Mechanical Design Engineer to develop, validate, and improve medical device designs for the Da Vinci SP system. You will lead mechanical efforts from concept through verification, working with manufacturing, quality, and clinical functions to meet customer needs and regulatory requirements.

The role emphasizes hands-on design, risk assessment, and process improvements to enable high-volume production, cost savings, and reliability enhancements across

Responsibilities

• Drive design efforts to optimize performance, manufacturability and reliability of Da Vinci SP instruments.
• Work cross-functionally with Manufacturing, Systems, Clinical Development, Supplier, and Quality engineers.
• Maintain awareness of customer needs and develop new device concepts and improvements.
• Provide mechanical engineering sustaining support for resolving manufacturing and field issues.
• Create product functional and design specifications.
• Analyze and test product designs.
• Develop vendors to manufacture components.
• Develop fixtures and processes to assemble components.
• Develop product assembly instructions.
• Develop and perform component verification testing and product validation testing.
• Support production by troubleshooting process and component problems.
• Support CAPA and quality/regulatory audits as required.
• Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to transfer designs.
• Develop and maintain Design History Files per FDA requirements.
• Investigate and establish root cause of design, manufacturing or material defects.
• Develop, implement, test and document solutions according to SOPs.

Job description

Intuitive in Sunnyvale, CA seeks a Senior Mechanical Design Engineer to develop, validate, and improve medical device designs for the Da Vinci SP system. You will lead mechanical efforts from concept through verification, working with manufacturing, quality, and clinical functions to meet customer needs and regulatory requirements.

The role emphasizes hands-on design, risk assessment, and process improvements to enable high-volume production, cost savings, and reliability enhancements across