Senior Mechanical Engineer - NPD for China Localization

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. 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. Essential Job Duties 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 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. 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 (8) years of experience with a bachelor’s degree in mechanical engineering or six (6) 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 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)