Senior Mechanical Engineer

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. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.