Intuitive Surgical Careers

Senior Electrical Engineer

US-CA-Sunnyvale, California
Engineering


Job Description

Job: Engineering
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 190525

Description

Company Description:

Intuitive Surgical: What Matters

Joining 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 Electric 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 Senior Electric Engineer will serve as an interface between JV 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 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.
Qualifications

Skill/Job Requirements: 
 
• BS or higher in Electric Eng, Bio Eng, or related engineering or scientific discipline required.
• Minimum 10 years of previous related experience in medical device development including hands on experience with all aspects of medical device related design control activities.
• Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer to Manufacturing
• Broad and deep understanding of registration process of Class II & Class III Active Medical Devices and associated Devices Design Controls regulations with emphasis on (CFDA, FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
• Experience with the submission, review and approval process of med devices to CFDA a strong plus
• 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 a strong plus
• Hands-on engineering with ability to work well in a team environment
• Excellent written and communication skills.
• Self-starter with ability to take leadership in a fast-paced environment. Ability to handle ambiguity and adapt to changes effectively and oversee multiple projects at once
• Fluent in English and Mandarin (read/write) a strong plus
• Ability to travel internationally 25% of the time


We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.