Sr. Clinical Development Engineer

Company Description 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  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.

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:

Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar

Minimum of 4 years of clinical development and design control experience including the MSExperienced in driving medical device products and features from concept to market

Experience collaborating with physicians and collecting feedback on clinical use of the…