Clinical Research Engineer - Future Forward

Intuitive•Sunnyvale, CA

11d•Onsite

About The Position

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 as regulatory, clinical affairs, finance, and more to develop the clinical indication and commercialization strategy. 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.

Requirements

Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or similar
5+ years of related experience in clinical engineering and/or product development within the medical device industry
Fluent in medical procedure terminology and sound knowledge of anatomy
Ability to understand complex robotic systems and software algorithms.
Experience working in an operating room or interventional suite environment.
Experience collaborating with physicians and collecting feedback on clinical use of the product.
Excellent mechanical and technical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products.
Excellent analytical capability and practical skills to develop and test a clinical hypothesis and draw succinct conclusions.
Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure timely project success.
Proven success recognizing critical issues and driving them to closure by taking coordinated action.
Product development and Design Controls experience required.
Familiar with intellectual property development and patent assessment
Effective communication skills (verbal, written, presentation)
Self-starter needing minimal supervision.
Self-confident and able to react quickly under pressure.
Must be available to work full-time and commute/relocate to Sunnyvale, CA

Nice To Haves

Experience with on-site clinical trial support a plus.

Responsibilities

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.
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.