International Society of Biomechanics
Gold sponsor

Clinical Development Engineer (All Levels)

Category
Engineering
Posted
25 Feb 2022
Modified
25 Feb 2022
City
Sunnyvale, California
Country
United States of America
Organisation
Intuitive Surgical


2022 Clinical Development Engineering Roles – Multiple Positions Open!




Title: Clinical Development Engineer (All Levels)


Are you an engineer who is passionate about deeply understanding the clinical needs of users to support development of products that advance robotic surgery?


Are you interested in being very hands on with technology, immersing yourself in the clinical space and serving as the voice of the surgeon during product development?


Come join Intuitive as a Clinical Development Engineer!


Since 1997, Clinical Development Engineers at Intuitive have played a role in shaping the rise of robotic surgery. Our team is currently 50+ strong and supports products across the Multiport, Singleport, and Digital Business Units in all phases of development.


Clinical Development Engineers provide breadth and depth of knowledge as well as hands on know-how in clinical requirements for technology (robotic systems, software, instruments, accessories, energy, stapling, endoscopes, imaging) across surgical specialties (urology, gynecology, cardiothoracic, colorectal, bariatrics, foregut, general surgery, head and neck) to ensure the safety, efficacy, and clinical value of all our product offerings.


Intuitive continues to innovate, and our team continues to grow! We have multiple Clinical Development Engineering positions open for candidates of varying levels of experience.



Roles and Responsibilities:


·       Understand and represent the voice of surgeons and clinical OR staff through hands-on testing of products in a simulated surgical environment


o   Develop surgical expertise by applying in-depth knowledge of surgical procedures, operating room environment, and da Vinci surgical systems in lab


o   Collaborate with marketing partners and clinicians to identify enhancements that meet clinical needs


·       Bring new products and product changes to market as part of the cross-functional project team by assessing device performance and influencing design


o   Establish clinical performance requirements and inform design specifications for safe and effective products


o   Conduct assessments of the clinical performance of prototype designs and provide feedback to the design engineering team on areas for improvement


o   Write protocols and conduct testing in a simulated surgical environment to formally validate the safety and efficacy of new or updated products as part of the design controls process


·       Perform and document clinical risk assessments to identify risks associated with using the device and their mitigations


·       Serve as clinical subject matter expert


o   Support regulatory documentation and submissions


o   Provide expertise to user manual and training development 


Skills, Experience, Education & Training:


Requirements:


·       Minimum of B.S. in Mechanical Engineering, Biomedical Engineering, or similar 


·       Minimum of 2 years of experience in medical device industry with level at hiring (Senior or Staff CDE) to be based on education and experience


·       Passion for hands-on lab-based work, including ex-vivo, in-vivo, and in-vitro models


·       Aptitude for distilling complex information into key concepts to communicate across both internal engineering and external medical audiences


·       Excellent ability to design robust experiments with sound test methods, perform data analysis, and draw data-driven conclusions 


·       Collaborative approach to facilitate building relationships across multiple disciplines as part of a project team


·       Experienced in recognizing and troubleshooting issues, from clinical safety to usability,  and driving execution of solutions and risk mitigations


·       Strong written communication skills and attention to detail to support regulatory submissions


·       Self-starter needing minimal supervision 


·       Ability to travel up to 15% of the time, internationally and domestic 



Preferences:


·       MD, MS or PhD in Mechanical Engineering, Biomedical Engineering, or similar


·       Extensive experience working with surgeons in an operating room environment


·       Fluent in surgical terminology with sound knowledge of anatomy and surgical technique 



To Apply:


Visit https://careers.intuitive.com/i/us/en/job/220333 (Job ID 220333)



Contact:


           Melanie Yuan, Manager Advanced Clinical Development Engineering


            Melanie.Yuan@intusurg.com