Senior Clinical Development Engineer - Advanced Energy

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 engineers, clinicians, and other internal and external stakeholders 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.

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

• 8+ years of experience in medical device industry with a Bachelor’s degree, or 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 ​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 mode Experience working with surgeons in an operating room environment. referred

Skills and Experience

Experience with on-site clinical trial support ​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 ​Composed and able to react quickly under pressure 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