Sr Clinical Development Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

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.

Roles and Responsibilities:

The responsibilities for this position include:

Clinical and Technical knowledge

• 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

Product Leadership

• 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

Design Control

• 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

Qualifications

Skill/Job Requirements:

• Minimum Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar
• Minimum of 5 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, p