Clinical Development Engineer - Advanced Energy

Job Description

Primary Function of the Position

The Clinical Development Engineer (CDE) uses their in-depth knowledge of the surgical environment and medical technology to work with engineers, clinicians, and other internal and external stakeholders to define, develop, and validate the clinical function of new products within our multi-port and single-port surgical robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical requirements to ensure a high-quality patient outcome. The individual will take an active role in the concept design team by assessing and communicating clinical risks, providing design guidance, inventing new concepts, and executing the overall clinical strategy.

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
• ​ Execute clinical studies to support technology development for regulatory and reimbursement strategies
• 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

• 5+ years of experience in medical device industry with a Bachelor’s degree, 3 years experience with a Master’s degree, or a PhD degree without experience. Minimum of Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or similar; advanced degree preferred
• ​Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
• Passion for hands-on lab-based work, including ex-vivo, in-vivo, and in-vitro models
• ​Excellent analytical capability and practical skills to develop test methods and draw conclusions

Preferred Skills and Experience

• ​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
• ​Composed and able to react quickly under pressure
• Experience working with surgeons in an operating room environment
• Experience with on-site clinical trial support
• ​Fluent in surgical terminology and sound knowledge of anatomy and surgical technique

​​Working Conditions ​

• ​Ability to travel up to 50% of the time, internationally and domestic

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.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a…