Intuitive Surgical Careers

Clinical Development Engineer

Sunnyvale, California
Clinical / Regulatory


Job Description

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

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. The Post Market Team advocates for safety and effectiveness improvements by assessing field product performance and QMS processes to identify, investigate, communicate, and execute on opportunities.

Primary Function of Position:

The Post Market Clinical Development Engineer (CDE) uses their in-depth knowledge of the da Vinci® Surgical System and clinical applications to investigate, understand, and address opportunities with products in the field. The Post Market CDE also works with failure analysis/design engineers and clinicians to define, develop, and validate the clinical function of product improvements within our surgical robotic system platforms. They investigate and refine products including robotic systems, visualization platforms, instruments and accessories that ultimately improve the clinical outcome for patients. Their primary focus is to ensure clinical requirements are met, risks are understood and characterized, and validate that the products address them. They will also investigate opportunities for product, clinical application, and process improvements based on clinical use experiences.

Roles and Responsibilities:
  • Apply in-depth knowledge of the operating room environment and of the da Vinci® Surgical System to become an expert within the company on the clinical application of Intuitive’s products
  • Work with regulatory surveillance, failure analysis engineering, clinical sales representatives, and surgeons, acting as a ‘detective’ to assess how use scenarios contribute to findings and address root cause 
  • Partner with Medical Safety Officer to characterize potential health hazards and feed evaluations to field action decision team
  • Take an active role in continuing engineering teams, including contributing to team meetings and design reviews, and providing design and testing guidance
  • Collaborate closely with product engineering to define and assess products against clinical performance goals for product improvements
  • Design, perform, and report on initial performance assessments of prototype designs 
  • Assess and document clinical risks, and advise engineering regarding risks and mitigations
  • Write protocols and conduct formal validation testing for product updates and releases, and modifications to existing designs, in order to validate the clinical safety and efficacy of the product. Support FDA/regulatory documentation and applications
  • Support and sometimes manage clinical evaluation of 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
  • Maintain up-to-date knowledge of clinical applications of the da Vinci® Surgical System, and transfer clinical product knowledge from new product development to the Post-Market space, including regulatory surveillance, failure analysis engineering, and training. 
  • Collaborate with other organizations within the company as needed, including new product development, regulatory, quality, marketing, human factors, training, and sales
  • Keep the patient, organization’s vision, and values at the forefront of decision making and action
  • Perform other duties as required to support the company's overall strategy and goals
Qualifications

Skill/Job Requirements
  • B.S. in Mechanical Engineering, Biomedical Engineering or similar
  • Minimum of 3 years of experience in medical device industry required
  • Experience working with surgeons in an operating room environment
  • Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
  • Penchant for investigation: root cause analysis, failure replication, scenario reenactment
  • Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
  • Experience with design control (risk analysis, validation, verification, testing) preferred, with a solid handle on design improvement validation methodology and application
  • Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to insure project success
  • Self-starter needing minimal supervision
  • Self-confident and able to react quickly under pressure
  • Excellent verbal and written communications skills required including presentation of technical content
  • 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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