Senior Mechanical Design Engineer

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

Job Description

Primary Function of Position

At Intuitive, we believe that minimally invasive care is life-enhancing care. By combining ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to deliver solutions urgently to our patients.

The Senior Mechanical Design Engineer is responsible for developing, documenting, and validating new product designs, as well as improving existing designs to meet the needs of our customers. This position requires a hands‑on, technically strong engineer to dive deep into solving engineering challenges, and to provide high‑level assessment of risks and opportunities. Projects will include a mix of sustaining existing products and new product development, including improvements for cost savings and manufacturability to enable significant volume growth, enhancements to increase customer satisfaction, and improving reliability.

Essential Job Duties

• Drive Design efforts to optimize performance, manufacturability and reliability of existing and future Da Vinci SP instruments.
• Work cross-functionally with Manufacturing Engineers, Systems Engineers, Systems Analysts, Clinical Development engineers, Supplier Engineers, Quality Engineers
• Maintain awareness of customer needs and requirements – develop new device concepts as well as continuously improving existing designs to meet those needs.
• Provide mechanical engineering sustaining support for resolution of manufacturing and field issues.
• Create product functional and design specifications
• Analyze and test product designs
• Develop vendors to manufacture components
• Develop initial fixtures and processes to assemble components
• Develop product assembly instructions
• Develop and perform component verification testing and product validation testing
• Support production of final product by troubleshooting process and component problems
• Support the CAPA and continuous improvement projects and quality/regulatory audits as required
• Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs.
• Develop and maintain Design History Files per FDA requirements
• Investigate and establish root cause of both latent and emerging design, manufacturing or material defects
• Develop, implement, test and document solutions for these opportunities according to corporate standard and departmental operating procedures