Intuitive Surgical Careers

Clinical Development Engineer

US-CA-Sunnyvale, California
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 180888

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.


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:

The Clinical Development Engineer (CDE) uses their in-depth knowledge of the da Vinci® Surgical System to work with design engineers and clinicians to develop safe and highly effective products for our multi-port surgical robotic system platforms. The CDE is responsible for establishing and validating data-driven clinical requirements to ensure a high quality patient outcome and for conveying the clinical value throughout the organization.

Roles and Responsibilities:

This position has responsibility and authority for the following:

New Product Development: 

• Applying in-depth knowledge of the operating room environment and of the da Vinci® Surgical System to become an expert on the clinical application of Intuitive’s products
• Collaborating closely with product management and product development teams to define clinical performance goals and potential risks for new products
• Collaborating with research teams to help with quick design iteration and assessment of products
• Assessing and documenting clinical risks, and advising engineering regarding risks and mitigations
• Work with clinical sales representatives, surgeons, and marketing to identify clinical needs and complementary devices in the marketplace
• Collaborate with other organizations within the company as needed: regulatory, human factors, training, quality, manufacturing, marketing and sales

Clinical Laboratory & Field Work:

• Conducting pre-clinical validations and design iteration assessments of products both internally and with external key opinion leaders
• Conducting formal validation testing for new products, product updates and modifications to existing designs, to ensure the clinical safety and efficacy of the product
• Support clinical evaluation of new or enhanced products at key customer sites
• Identify potential product enhancements & new product ideas by applying an analytical approach to understanding the clinical needs of surgeons

Design History:

• Product Requirement Documents (owning clinical requirements)
• Clinical Risk Analysis (owner)
• Clinical Design Validation, Protocols & Reports (owner)
• 510K/regulatory submission content (subject matter expert)
• User manual and training documentation (subject matter expert)

Other:

• Keeps the organization’s vision and values at the forefront of decision making and action
• Performs other duties as required to support the company's overall strategy and goals
Qualifications

Skill/Job Requirements:

To adequately perform the responsibilities of this position the individual must have: 

• Minimum of B.S. in Mechanical Engineering, Biomedical Engineering or similar
• Minimum of 3 years of experience in medical device industry
• Experience working with surgeons in an operating room environment
• Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
• Excellent mechanical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products
• Excellent analytical capability and practical skills to develop and test a thesis and draw succinct conclusions
• Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to insure timely project success
• Effective communication skills (verbal, written, presentation)
• Proven success recognizing critical issues and driving them to closure by taking coordinated action
• Self-starter needing minimal supervision
• Self-confident and able to react quickly under pressure
• Ability to travel up to 30% of the time, internationally and domestic

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.

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