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 at **Intuitive**. As a global leader in **robotic-assisted surger** y 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.
Were 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.
The **Future Forward** organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.
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
The Sr. Manager Clinical Research Engineering uses their in-depth clinical, scientific, and technical knowledge to lead, collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The individual brings their clinical device development expertise to new platform and technology development, and is responsible for identifying, documenting, and understanding user needs and subsequently communicating these needs to inform concept design and development.
Responsibilities
Advanced research lead and new product concept development
- Leads research on disease states and medical technologies associated with new business opportunities for Intuitive and applying their in-depth knowledge to become an expert within the company on the new products being developed and their clinical application.
- Key stakeholder, collaborates closely with engineers and physicians to define clinical performance goals and potential risks for new products in early phase pf development.
- Manages, collects, and decipher VOC across various levels of management.
- Creates plans for 3-year timeframes for clinically complex programs. Manages and proposes budget, sets overall program goals and aligns with executive leadership.
- Monitors and advices complex technical and clinical aspects of the product.
- Hire, develop and mentor CREs for the program,
- Presents findings to key opinion leaders, subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design and development of new platforms, procedures, instruments, and accessories.
- Collaborate with other organizations within the company as needed leading the clinical aspects of new programs and platform development: design engineering, regulatory, human factors, industrial design, training, marketing, and others.
- Develop and execute clinical de-risking pathways including both pre-clinical and clinical feasibility studies.
- Contribute to market development and segmentation for new clinical applications.
Clinical innovation
- Develop novel clinical models and metrics for technology evaluation and prototype performance assessment.
- Develop novel procedures and workflows for new technologies.
- Design, develop, and execute clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration.
- Conduct design iteration assessments of products both internally and with external key opinion leaders.
- Identify and drive product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users.
- Develop and execute a preclinical evaluation strategy in advance of human trials and for regulatory submissions.
- Lead and execute early-stage feasibility, pilot, and pivotal studies to support technology development for regulatory and reimbursement strategies.
- Develop intellectual property for novel clinical applications and technologies.
- Keep the organization’s vision and values at the forefront of decision making and action.
- Perform other duties as required to support the company's overall strategy and goals.
