Clinical Research Engineer

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Intuitive is seeking a Clinical Research Engineer to combine clinical, scientific, and technical expertise in early exploration of new product concepts. You will identify user needs, design clinical strategies, and collaborate across disciplines to advance platform development and commercialization plans.

The role emphasizes leading de-risking efforts, performing clinical evaluations, and translating physician insights into design guidance for new technologies.

Responsibilities

• Advanced research and new product concept development for clinical applications.
• Collaborate with engineers and physicians to define clinical performance goals and risks.
• Identify clinical goals with key opinion leaders and translate needs for user-centric design.
• Partner with regulatory, clinical affairs, finance and other teams to develop clinical strategy.
• Develop and execute clinical de-risking pathways including pre-clinical and feasibility studies.
• Lead clinical evaluations and communicate feedback to accelerate technology development.
• Drive product enhancements and new ideas by analyzing clinical needs of physicians and users.
• Lead early-stage studies to support regulatory and reimbursement strategies.

Job description

Job Description

The Clinical Research Engineer uses their in-depth clinical, scientific, and technical knowledge to 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. The Clinical Research Engineer is responsible for developing and executing an experimental strategy to assess performance and safety of prototype designs and is a key contributor in the design and development iteration process. The individual will take an active role in the concept design team by assessing and communicating clinical risks, providing design guidance, inventing new concepts, and executing the overall clinical strategy. The Clinical Research Engineer also partners closely with team members such regulatory, clinical affairs, finance, and more to develop the clinical indication and commercialization strategy.

Responsibilities

This position has responsibility and authority for the following:

Advanced research and new product concept development

• Research 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.
• Collaborate closely with engineers and physicians to define clinical performance goals and potential risks for new products in early phase development.
• Work with 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 derisking 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.

Other

• 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.