Senior Mechanical Engineer

Intuitive • Sunnyvale, CA

6d

About The Position

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. The Senior Mechanical Engineer is responsible for supporting Intuitive Surgical and JV’s New Product Development (NPD) team focused on the development, localization, and launch of various robotic-assisted platforms in China.

Requirements

• Strong understanding of design for reliability, robustness, and manufacturing.
• Proficiency using CAD to design and document mechanisms; SolidWorks preferred
• Self-motivated, hands-on, and the ability to work well within a fast-paced team-oriented environment.
• Ability to handle ambiguity and adapt to changes effectively and oversee multiple projects at once
• Excellent communication (written, verbal), presentation and documentation skills
• Minimum of eight (8) years of experience with a bachelor’s degree in mechanical engineering or six (6) years of experience with a master’s degree.

Nice To Haves

• Knowledge of experience in China regulations, technical guidelines, and submission pathway
• Strong analysis skills, and knowledge of engineering tools that drive design excellence
• Experience transferring manufacturing lines to remote sites a strong plus
• Experience with submitting med devices to regulatory agency, like NMPA, a strong plus
• Fluent in English and Mandarin (read/write) a strong plus
• Broad and deep understanding of Requirement Management and Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971, NMPA)

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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees