Sr. Manager Clinical Research Engineering

Intuitive; Sunnyvale (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Intuitive is seeking a Sr. Manager Clinical Research Engineering to lead cross‑functional teams of engineers, physicians, UX researchers, and other stakeholders in developing new product concepts at the earliest stages.

You will apply clinical device development expertise to inform concept design, drive clinical performance goals, manage de‑risking programs, and mentor CREs as the organization advances platform development.

Responsibilities

• Leads research on disease states and medical technologies for new 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.
• Defines clinical performance goals and potential risks for new products in early phase development.
• Manages, collects, and interprets VOC across various levels of management.
• Creates plans for 3-year timeframes for clinically complex programs. Manages budgets and aligns with executive leadership.
• Presents findings to key opinion leaders and translates needs for user-centric design and development.

Job description

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.