Clinical Development Engineer

The Post Market Clinical Development Engineer uses their indepth knowledge of the surgical environment and medical technology to investigate understand and address opportunities with products in the field work. The Post Market CDE also works with failure analysis/design engineers and clinicians to define develop and validate the clinical function of product improvements within our surgical robotic system platforms. They investigate and refine products including robotic systems visualization platforms instruments and accessories that ultimately improve the clinical outcome for patients. The primary focus of the CDE is to establish and validate datadriven clinical requirements to ensure a highquality patient outcome.

Roles & Responsibilities:

• Apply indepth 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 Intuitives products
• Work with regulatory surveillance failure analysis engineering clinical sales representatives and surgeons acting as a detective to assess how use scenarios contribute to findings and address root cause
• Partner with Medical Safety Officer to characterize potential health hazards and feed evaluations to field action decision team
• Provide a clinical voice to product development by defining and assessing clinical performance of legacy products
• Collaborate closely with product engineering to define and assess products against clinical performance goals for product improvements
• Use an analytical approach to identify potential product enhancements
• Take an active role in sustaining engineering teams including contributing to design reviews and providing design guidance to engineering design teams
• Assess and document clinical risks and identify appropriate mitigations
• Conduct preclinical testing to validate the safety and efficacy of new products
• Write protocols and conduct formal validation testing for product updates and releases and modifications to existing designs in order to validate the clinical safety and efficacy of the product. Support FDA/regulatory documentation and applications
• Provide subject matter expertise to user manual and training documentation development
• Maintain current knowledge of clinical applications of Intuitives products
• Collaborate with other organizations within the company as needed including new product development regulatory quality marketing human factors training and sales
• Keep Intuitives vision and values at the forefront of decision making
• Perform other duties as required to support the companys overall strategy and goals

Qualifications :

Skills Experience Education & Training:

• Minimum of B.S. in Mechanical Engineering Biomedical Engineering or similar advanced degree preferred
• Minimum of 5 years of experience in medical device industry with a B.S 3 years experience with an M.S or a PhD without experience
• Experience working in Risk Management specifically in ISO 14971
• Experience working with surgeons in an operating room environment
• Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
• Excellent mechanical aptitude and intuition for spatial relations including the ability to understand complex mechanical products
• 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
• Selfstarter needing minimal supervision
• Selfconfident and able to react quickly under pressure
• Ability to travel up to 25% 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 COVID19.  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

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive 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 salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime