8+ years in medical device industry with a Bachelor's, 6 years with a Master's, or 3 years with a PhD
Experience supporting medical products from design to launch
Familiarity with operating room environments and working with surgeons
Fluency in surgical terminology and knowledge of anatomy
Mechanical aptitude for understanding complex products
Analytical skills for developing test methods and conclusions
Responsibilities
Apply expertise in the surgical environment to guide product development
Define and assess clinical performance of new products
Collaborate with marketing and clinicians to identify clinical needs
Identify product enhancements and new ideas through analysis
Contribute to design reviews and provide guidance to engineering teams
Assess clinical risks and document appropriate mitigations
Conduct pre-clinical testing to validate product safety and efficacy
Benefits
Ability to travel up to 25% of the time
Market-competitive compensation packages
Opportunities for professional development
Collaborative work environment
Supportive of work-life balance
Full Job 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.
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
Qualifications
Required Skills and Experience
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
Mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
Analytical capability and practical skills to develop test methods and draw conclusions
Nice to have
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
Working Conditions
Ability to travel up to 25% of the time
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
About Intuitive Surgical, Inc
Intuitive Surgical, Inc. is an American corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System. The company is part of the NASDAQ-100 and S&P 500. Intuitive Surgical has installed more than 5,000 surgical systems worldwide, and has more than 4,000 employees.
