Senior Clinical Development Engineer

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 single-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.

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

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
• VoC experience with surgeons to discuss products and workflow
• Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products

Nice to haves

• 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, or similar; advanced degree preferred

Working Conditions

Ability to travel up to 25% of the time, internationally and domestic