Intuitive Surgical Careers

Senior Clinical Development Engineer, China Integration

Sunnyvale, California
Clinical / Regulatory


Job Description

Job: Clinical / Regulatory
Primary Location: United States-California-Santa Clara County-Sunnyvale
Schedule: Full-time

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.  

This Joint Venture will be looking for a Sr. Clinical Development Engineer responsible for training, education and supervision of a high performing regional clinical support staff that will support physicians before and during the duration of a multicenter clinical trial in China.

Thereafter the candidate would transition to California and support the clinical device engineering team in driving and evaluating new and enhanced product designs. In this role, the candidate works with design engineering, marketing and clinician teams to define, develop and validate new medical robotic systems, instruments and accessories and is responsible for establishing and validating clinical requirements as part of product development.

The work of this full-time role is expected to last 18-24 months while the Joint Venture becomes fully operational. This role will require 30-50% travel to China.

Roles and Responsibilities:

Clinical Trial Support for JV

• Become an expert in understanding the clinical subspecialty landscape, as well as develop in-depth knowledge of the medical device functionality, capabilities and clinical applications prior to clinical trial start. During this time, frequent travels to California are expected.
• Be responsible for clinical product education & training process of a high performing regional clinical support staff (e.g. MD’s) to be facile in pre, intra, and postoperative system management
• Assist in developing a clinical trial strategy and design, as well as support trial execution in conjunction with ISI & JV Clinical- and Clinical Affairs teams.
• Supervise and support the clinical trial together with “In-suite-trial managers” and provide physician guidance and device-related instructions as needed.
• Support and manage clinical evaluation of new or enhanced products at customer sites.
• Facilitate information exchange between engineering team in California and clinical support staff in China.


Product Development

• Apply in-depth knowledge of the operating room and/or endoscopy environment and of medical technology in order to become an expert on the clinical application of the existing products.
• Identify prospective product enhancements, ideas & associated clinical risks through analytical assessment.
• Collaborate closely with product management and product development to define and validate clinical performance goals for new products.
• Lead physician teams through training sessions, helping them understand system operations, OR or Endoscopy Suite integration and applications.
• Identify and develop bench and pre-clinical models to evaluate performance of new product prototypes.
• Author design control documentation including requirements writing and risk management activities.
• Develop pre-clinical testing protocols and conduct testing to evaluate clinical risks associated with new product applications or updates.
• Conduct pre-clinical validations and design iteration assessments of products both internally and with external key opinion leaders.
• Conduct formal validation testing for new products, product updates and modifications to existing designs, to ensure the clinical safety and efficacy of the product
• Support regulatory documentation for submission.
• Represent the voice of the customer for prototype evaluations.
• Support clinical evaluation of new or enhanced products at key customer sites. Support customer training for new features under evaluation.
• Author field feedback reports to product development comparing real world performance vs expected performance, identify unmet needs and represent the voice of the customer
• Collaborate with other organizations within the company as needed, including regulatory affairs, clinical affairs, human factors, customer education and training, and sales.
Qualifications

Skill/Job Requirements: 

• MS, Phd (Biomedical Engineering, Mechanical Engineering or equivalent field),
or MD in scientific field is required.
• Bilingual English-Mandarin (fluency in both)
• Able to work in both US and China with up to 50% travel
• Min 6 years of experience working in the medical device industry with extensive knowledge of anatomy and clinical language proficiency.
• Experience with design controls and product development activities in a medical device industry
• Sound knowledge of endoscopic techniques
• Experience working with physicians in an operating room or endoscopy room environment and proven clinical credibility.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Experience in providing work direction for others and have mentoring and interpersonal skills to train & manage a clinical support staff in China.
• Strong communication, presentation and interpersonal skills with high attention to detail and organization. Must be able to work effectively on cross-functional teams.
• Consistently shows dedication or strong work-ethic to help meet aggressive timelines when necessary
• Successful introduction of new technologies to the market preferred


We are an AA/EEO/Veterans/Disabled employer.
 
#LI-CH1

#LI-CH1