Senior Clinical Development Engineer for Digital Products

4 weeks ago

Sunnyvale, California, United States Intuitive Full time
Company Overview

At Intuitive, we are driven by a shared mission to revolutionize minimally invasive care. Through innovative technology and collaboration, we empower physicians to deliver life-enhancing care without constraints.

Job Description

Primary Function of the Position

The Senior Digital Clinical Development Engineer plays a critical role in defining, developing, and validating the clinical function of new digital products within our multi-port and single-port surgical robotic platforms. This position requires a deep understanding of the surgical environment and medical technology to collaborate with design engineers and clinicians.

Essential Job Duties

  • Apply in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert within the company on the clinical application of Intuitive's products
  • Provide a clinical voice to product development by defining and assessing clinical performance of new products
  • Collaborate with marketing partners and clinicians to identify and understand clinical needs
  • Use an analytical approach to identify potential product enhancements and new product ideas
  • Take an active role in new product development teams, including contributing to design reviews, and providing design guidance to engineering design teams
  • Assess and document clinical risks, and identify appropriate mitigations
  • Conduct pre-clinical testing to validate the safety and efficacy of new products
  • Support regulatory documentation and submissions
  • Provide subject matter expertise to user manual and training documentation development
  • Support clinical evaluation of new products at key customer sites
  • Maintain current knowledge of clinical applications of Intuitive's products
  • Keep Intuitive's vision and values at the forefront of decision making
  • Perform other duties as required to support the company's overall strategy and goals
  • Assist in the preparation of regulatory submissions, such as 510(k)s or IDEs, ensuring compliance with relevant regulatory requirements
Qualifications

Required Skills and Experience

  • Minimum of 8 years of experience in medical device industry with a Bachelor's degree, 6 years experience with a Master's degree, or 3 years with a PhD degree
  • 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 test methods and draw conclusions
  • Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines
  • 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

Required Education and Training

  • Minimum of Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, Software Engineering, or similar; advanced degree preferred

Working Conditions

  • Ability to travel up to 25% of the time, international and domestic
  • Ability to see all colors, have stereoscopic vision, and have near and far visual acuity (clarity between 12 inches and 20 feet with or without corrective lenses)
  • Ability to work standing for several hours in an OR environment

Preferred Skills and Experience

  • 5+ years experience in software development or clinical engineering, with a focus on medical devices or healthcare applications

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