Sr. Clinical Development Engineer

Intuitive•Sunnyvale, CA

About The Position

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here. This Sr. Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, Sr. CDE utilizes their in-depth clinical, technical and design control knowledge to collaborate with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks and identify solutions to guide product development. This position will also allow exploration of future robotic clinical applications and solutions.

Requirements

Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar
Minimum of 6 years of clinical development and design control experience
Experienced in driving products and features from concept to market
Experience collaborating with physicians and collecting feedback on clinical use of the product
Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to ensure project success
Experience understanding clinical harms and performing clinical risk analysis
Experience developing design validation strategy, protocol creation and testing
Experience leading hands-on product evaluation testing in a pre-clinical lab setting
Fluent in medical terminology and sound knowledge of anatomy
Self-starter needing minimal supervision
Self-confident and able to react quickly under pressure
Ability to adapt priorities in a fast paced, dynamic, product development team
Excellent verbal and written communications skills including presentation of technical content
Ability to travel up to 25% of the time, internationally and domestic

Responsibilities

Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs
Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback
Clearly define clinical need and requirements for product
Develop test models and test methods for clinically relevant product evaluations.
Assess potential clinical risks and propose mitigations as an input to product design
Observe cases and communicate assessment of robotic value and/or opportunities
Contribute expertise into clinical protocol design and strategy
Participate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas.
Drive frequent stakeholder alignment and solicit appropriate user feedback
Drive decision making and escalate key issues quickly
Keep the organization’s vision and values at the forefront of decision making and action
Educate cross functional team on clinical workflow
Support product launches and/or clinical trials and collect early field feedback
Conduct clinical risk analysis for new products or updates
Lead testing and clinical evaluations of new product features
Collaborate with cross functional team members including regulatory, human factors, training, engineering and product management to determine design and development key inputs
Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders