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Sr. Clinical Development Engineer Advanced Development

Sr. Clinical Development Engineer Advanced Development

CompanyIntuitive Surgical
LocationSunnyvale, CA, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s, Master’s, PhD
Experience LevelSenior

Description

Job Description

Primary Function of the Position

The Senior Clinical Development Engineer (CDE) uses their in-depth knowledge of the surgical environment and medical technology to work with design engineers and clinicians to define, develop, and validate the clinical function of new products within our multi-port robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical requirements to ensure a high-quality patient outcome. This role supports Multiport Systems Advanced Development.

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 a data-based approach to identify potential product enhancements and new product ideas
  • ​Take a dynamic 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

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
  • Proven experience in supporting a medical product from design to launch
  • ​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 data-backed 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
  • ​Poised and able to react quickly under pressure

Required Education and Training

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

Working Conditions

  • Ability to travel up to 25% of the time, internationally and domestic
  • For positions related to development of the optical/vision system, the ability to have near and far visual acuity (clarity between 12 inches and 20 feet with or without corrective lenses), stereoscopy, and the ability to see all colors is required.

Preferred Skills and Experience

  • None

Benefits

Not Specified