Senior Mechanical Engineer

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical, Sunnyvale, CA, seeks a technical contributor to support the robotic platform product line, focusing on documentation, test methods, and design input work for the China market.

The role requires collaboration with product development teams, regulatory labs, and project management to meet certification timelines and ensure compliance throughout the product lifecycle.

Responsibilities

• Become intimately familiar with all technical and documentation aspects for a robotic platform product line.
• Be a direct technical contributor for development activities related to product launch in China, including creating design input documents, developing test methods, executing design verification testing, and preparing technical submission dossiers to regulatory bodies
• Partner with product development teams and NRTLs to achieve product certification and regulatory approvals per project timelines.
• Work closely with design teams and project management to proactively mitigate risk from compliance issues through proactive participation in design reviews and early compliance testing of prototypes.
• Familiarity with all phases of the product development lifecycle and ensure Design Control processes are followed per relevant internal procedures & external regulations

Job description

Job Description

Primary Function of the Position
Intuitive Surgical (ISI) has established a preeminent position in surgical robotics with a presence in more than 60
countries around the world. China represents a key market to Intuitive that has unprecedented growth
opportunities driven largely by unmet patient and disease needs.
A Joint Venture (JV) between ISI and Fosun Pharma – a subsidiary of Fosun International, a leading Pharma and
Medical Device Company in China – has been established to accelerate the opportunities within this key market.
The intent of the JV is to research, develop, and manufacture innovative, robotic-assisted medical devices.

• Become intimately familiar with all technical and documentation aspects for a robotic platform product line.
• Be a direct technical contributor for development activities related to product launch in China, including creating design input documents, developing test methods, executing design verification testing, and preparing technical submission dossiers to regulatory bodies
• Partner with product development teams and NRTLs (Nationally Recognized Test Labs) to achieve product certification and regulatory approvals per project timelines.
• Work closely with design teams and project management to proactively mitigate risk from compliance issues through proactive participation in design reviews and early compliance testing of prototypes.
• Familiarity with all phases of the product development lifecycle and ensure Design Control processes are followed per relevant internal procedures & external regulations