Clinical Research Engineer - Future Forward

About the role

The Clinical Research Engineer at Intuitive plays a crucial role in the development of new robotic-assisted surgical technologies. They collaborate with engineers, physicians, and other stakeholders to define clinical performance goals, translate clinical needs into user-centric design, and lead clinical evaluations of prototypes.

Responsibilities

• Advanced research and new product concept development
• Research disease states and medical technologies associated with new business opportunities
• Collaborate with engineers and physicians to define clinical performance goals and potential risks for new products in early phase development
• Collaborate 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
• Develop and execute clinical derisking pathways including both pre-clinical and clinical feasibility studies
• Contribute to market development and segmentation for new clinical applications
• Develop novel clinical models and metrics for technology evaluation and prototype performance assessment
• Design, develop, and execute clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration
• 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 and reimbursement strategies
• 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
• Perform other duties as required to support the company's overall strategy and goals

Qualifications

• A minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or a similar field
• Minimum of 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
• Experience working in an operating room or interventional suite environment
• Experience collaborating with physicians and collecting feedback on clinical use of the product
• Experience with on-site clinical trial support a plus
• 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