Senior Mechanical Engineer

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.
Essential Job Duties
The Senior Mechanical Engineer will facilitate mechanical, hardware, and software integration of new prototypes
and new products including complete systems, instruments and components in China.
• 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

Qualifications

Required Skills and Experience
• 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.
• Strong analytical and problem-solving skills, with experience leveraging engineering tools and methodologies
to drive design excellence.
• Ability to handle ambiguity and adapt to changes effectively and oversee multiple projects at once
• Excellent communication (written, verbal), presentation and documentation skills
Required Education and Training
• Minimum of eight years of experience with a bachelor’s degree in mechanical engineering or six years of
experience with a master’s degree.

Working Conditions
• Ability to travel up to 10% of the time.
Preferred Skills and Experience
• Knowledge of China regulatory requirements, technical guidelines, and medical device submission pathways;
experience navigating the China regulatory landscape is highly preferred.
• Hands-on experience with hardware compliance testing, including IEC 60601 and related medical device
standards.
• Knowledge of pre-clinical and clinical study strategies for medical devices, including planning, execution, and
regulatory considerations.
• Experience leading or supporting manufacturing line transfers to remote or international sites.
• Fluency in English and Mandarin (reading, writing, and speaking) is highly preferred.
• Broad and deep understanding of requirements management and medical device design control regulations
and standards, including FDA Quality System Regulation (21 CFR Part 820), QSIT, EU MDR, ISO 13485, ISO
14971, and NMPA requirements.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

…