Senior Clinical Research 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

The Senior Clinical Research Engineer, Future Forward, will lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise. This team member will collaborate closely with engineers, physicians, interaction designers, human factors, training and technical publication specialists, and various internal and external stakeholders to guide product and procedure development. The Senior Clinical Research Engineer will play a key role in proctoring early-stage feasibility clinical studies, gathering case insights to support technology advancement, identifying and documenting user needs, managing product requirements, assessing clinical risks, and providing design guidance for clinical and commercial design and development. This team member will develop and execute pre-clinical experimental strategies to evaluate device performance, safety, and usability through the Product Development Process (PDP) ensuring readiness for commerical launch. The Senior Clinical Research Engineer will also work with cross-functional teams—including regulatory, quality, clinical affairs, and finance—to shape clinical indications and commercialization strategies, driving the technology from concept to a commercial-ready product.

Essential Job Duties

The Senior Clinical Research Engineer will:

Pre-clinical research and commercial concept development:

• Lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise.
• Research disease states and medical technologies associated with new business opportunities to become skilled on new products and their clinical applications.
• ​Collaborate with marketing partners and clinicians to identify and understand marketing needs.
• Work with key opinion leaders, subject matter experts, and other stakeholders to identify clinical goals and translate those needs into user-centric designs for new platforms, procedures, instruments, and accessories.
• Collaborate closely with engineers and physicians to define and evaluate clinical performance goals, potential safety and usability risks for new products in early-phase development.
• Develop and execute clinical derisking pathways, including pre-clinical and clinical feasibility studies, to ensure technology advancement and readiness for commercial launch.
• Conduct design iteration assessments of products both internally and with external key opinion leaders.
• Develop and execute a preclinical evaluation strategy in advance of human trials and for regulatory submissions.
• Provide subject matter expertise to user manual and training documentation development.
• Support regulatory documentation and submissions.
• Demonstrate a data-based approach to identify potential product enhancements and new product ideas.

Clinical research and innovation:

• Lead and execute early-stage feasibility clinical studies, pilot and pivotal clinical trials to support technology development for regulatory and reimbursement strategies.
• Identify and drive product enhancements and new product ideas by applying a data-based approach to understanding the clinical needs of physicians