Senior Mechanical Engineer, China NPD & Localization

Socket.dev; Sunnyvale (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Intuitive Surgical (ISI) seeks a Senior Mechanical Engineer to support NPD for robotic platforms in China via a Fosun Pharma JV. You will develop, localize and launch devices, create design inputs, run tests, and prepare regulatory submissions.

Requires 8+ years with a B.S. in mechanical engineering or 6+ years with an M.S., strong CAD skills (SolidWorks preferred), and design control/regulatory experience. Travel up to 10% may be needed.

Qualifications

• Minimum eight years' experience with a Bachelor's in mechanical engineering.
• Six years with a Master's degree.
• Experience with regulatory submissions and medical device design controls.

Responsibilities

• Develop and launch robotic platform products for China JV.
• Create design input documents, develop test methods, and execute design verification testing.
• Coordinate with product teams and NRTLs to achieve regulatory approvals.
• Mitigate compliance risks through design reviews and early testing.
• Ensure adherence to Design Control processes and regulatory requirements.

Skills

Design for reliability

CAD design

SolidWorks

Project coordination

Communication skills

Education

Bachelors in Mechanical Engineering

Masters in Mechanical Engineering

Tools

CAD software

Job description

Intuitive Surgical (ISI) seeks a Senior Mechanical Engineer to support NPD for robotic platforms in China via a Fosun Pharma JV. You will develop, localize and launch devices, create design inputs, run tests, and prepare regulatory submissions.

Requires 8+ years with a B.S. in mechanical engineering or 6+ years with an M.S., strong CAD skills (SolidWorks preferred), and design control/regulatory experience. Travel up to 10% may be needed.