Company Description: Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
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 Intuitiveroducts
- 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/Chronic Animal Study/Histopathology Protocols & Reports (owner)
- 510K/regulatory submission content (subject matter expert)
- User manual and training documentation (subject matter expert)
Other
- Keeps the organizationision 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 40% of the time, internationally and domestic
We are an AA/EEO/Veterans/Disabled employer.
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