Intuitive Surgical Careers
Senior Mechanical Engineer
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183344
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 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 Senior Mechanical 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.
- BS or higher in Physics, Mech Eng, Materials Science, or related engineering or scientific discipline required, MS Preferred.
- 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. Experience with plastics, injection molding, or disposable medical products are a strong plus
- Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer to Manufacturing
- Proficiency using CAD to design and document mechanisms; SolidWorks preferred
- Hands-on engineering with ability to work well in a team environment
- Excellent written and communication skills.
- Experience transferring manufacturing lines to remote sites a strong plus
- Understanding of third party agency testing (biocompatibility, sterilization assurance) in the US. Similar experience in China a strong plus.
- Experience with submitting med devices to CFDA a strong plus
- 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
- 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 a strong plus.
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.