Staff Mechanical Design Engineer - Instruments

Intuitive; Sunnyvale (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Intuitive is seeking a Mechanical Design Engineer to lead the design process for Da Vinci SP instruments, developing, testing, documenting, verifying and validating new product designs with a Patient-First mindset.

You will drive design optimization for performance, manufacturability and reliability, collaborating with Manufacturing, Systems, and Supplier Engineers, and contributing to FDA Design History Files and design verification activities in a fast-paced medical-device environment.

Responsibilities

• Drive Design efforts to optimize performance, manufacturability and reliability of existing and future Da Vinci SP instruments.
• Work and lead the design cross-functionally with Manufacturing Engineers, Systems Engineers, Systems Analysts, Clinical Development engineers, Supplier Engineers
• Maintain awareness of customer needs and requirements – develop new device concepts as well as continuously improving existing designs to meet those needs.
• Identify and Quantify Design Risks through Failure Modes and Effects Analysis (FMEA)
• Create product, functional, and design specifications
• Analyze and test product designs
• Develop vendors to manufacture components
• Develop initial fixtures and processes to assemble components
• Participate in clinical labs with appropriate surgical models (Cadaver, Animal, Tissue Analogs)
• Develop product assembly instructions in conjunction with Manufacturing
• Develop and perform component verification testing and product validation testing
• Support production of final product by troubleshooting process and component problems
• Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs.
• Develop 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

Job description

Job Description

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 a team member with exceptional character who has the capacity to simplify complex problems and the energy to deliver solutions urgently to our patients.
The Mechanical Design Engineer is responsible for leading the design process.
They shall do so by developing, testing, documenting, verifying, and validating new product designs, as well as improving existing designs, with a Patient-First mentality towards furthering the frontier of surgery.

Essential Job Duties

• Drive Design efforts to optimize performance, manufacturability and reliability of existing and future Da Vinci SP instruments.
• Work and lead the design cross-functionally with Manufacturing Engineers, Systems Engineers, Systems Analysts, Clinical Development engineers, Supplier Engineers
• Maintain awareness of customer needs and requirements – develop new device concepts as well as continuously improving existing designs to meet those needs.
• Identify and Quantify Design Risks through Failure Modes and Effects Analysis (FMEA)
• Create product, functional, and design specifications
• Analyze and test product designs
• Develop vendors to manufacture components
• Develop initial fixtures and processes to assemble components
• Participate in clinical labs with appropriate surgical models (Cadaver, Animal, Tissue Analogs)
• Develop product assembly instructions in conjunction with Manufacturing
• Develop and perform component verification testing and product validation testing
• Support production of final product by troubleshooting process and component problems
• Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs.
• Develop 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