Intuitive Surgical Careers
Senior Program Manager
Primary Location: United States-California-Santa Clara County-Sunnyvale
Intuitive Surgical: What MattersJoining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
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 Senior Program Manager 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 Sr. Project Manager will be the primary interface between external industry partners and the new product development team and will coordinate various aspects related to the product launch in China.
Roles and Responsibilities:
- Be a direct technical contributor for development activities related to product launch in China addressing the national differences according to the YY, GB standards (i.e. specific testing, product configurations, labeling, etc.).- Ensuring compliance with global design control requirements and associated deliverables for commercialization in China including Design History File (DHF), Device Master Record (DMR), regulatory submissions documents, etc.- Drafting product documentation to support the DMR associated with Chinese configurations.- Establishing the strategy and architecture for both short term and long term sustainability of product within the Chinese market- Planning and coordination through a cross functional teams based in both the US and China to achieve program goals.- Becoming intimately familiar with all technical and documentation aspects for an robotic platform product line- Manage inputs from various stakeholders both internally and externally, that include but not limited to: testing, engineering, regulatory, quality, clinical, and marketing.
- Bachelor’s Degree required, Master’s degree preferred, in Mech Eng, Electrical Engineering, Computer Science or other technical field. MBA a plus.
- Strong technical experience as an individual contributor and/or manager with deep expertise in one of the following areas: robotics, instrument design, accessories design, software design and testing, board design and testing, medical imaging
- 5+ years of previous related experience in medical device development, requirements management, and/or regulatory documentation
- Ability to travel internationally 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
- Experience transferring manufacturing lines to remote sites a strong plus
- Broad and deep understanding of Requirement Management and Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
- Strong planning, decision making, communication and presentation skills
- Ability to handle ambiguity effectively and oversee multiple projects at once
- Proficiency using CAD to design and document mechanisms a strong plus (SolidWorks preferred)
We are an AA/EEO/Veterans/Disabled employer.