Primary Function of Position:
Intuitive Surgical (ISI) has established the preeminent position in surgical robotics with 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 catheter-based medical devices.
We are seeking a Mechanical Engineer to support Intuitive Surgical’s New Product Development team focused on the development and launch of a new robotics platform in the US and China. The Mechanical Engineer will serve as an interface between Nationally Recognized Test Labs in the US and China and the new product development team and will play a major role in creating and maintaining a variety of key documents needed for various international regulatory submissions.
Roles and Responsibilities:
- Becoming intimately familiar with all technical and documentation aspects for an robotic platform product line
- Be a direct technical contributor for development activities related to product launch in China
- Partner with project management, 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.
- Monitor NRTL performance and take steps to adjust if needed.
- Master’s Degree required in Mech Eng, Electrical Engineering, Computer Science or other technical field. - 2 to 4 years of previous related experience in medical device development including hands on experience with all aspects of medical device related design control activities- Strong technical experience as an individual contributor and/or manager with deep expertise in one of the following areas: robotics, mechanical testing, software design and testing, board design and testing, medical imaging- Ability to travelinternationally 25% of the time- Passion for helping teams efficiently create fully documented, robust, and reliable medical devices- Fluent in English and Mandarin (read/write). Technical mandarin a plus- Experience with submitting medical devices to CFDA a strong plus- Broad and deep understanding of Requirement Management and Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971, CFDA)- Demonstrated knowledge of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) and statutory standards (EN60601-1, EN60601-1-2, GB, YY) in both US and China.
Requisition ID: 190852