Clinical Engineer

Clinical Engineer

Requirements

• Fluent in medical procedure terminology and sound knowledge of anatomy
• Ability to understand complex robotic systems and software algorithms
• Excellent mechanical and technical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products
• Excellent data-based 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
• Effective communication skills (verbal, written, presentation)
• Self-starter needing minimal supervision
• Self-assured and able to react quickly under pressure
• Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or similar
• At least 5+ years of related experience in clinical engineering and/or product development within the medical device industry

Responsibilities

• Research disease states and medical technologies associated with new business opportunities for Intuitive, and apply their in-depth knowledge in order to become experienced 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, etc.
• 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
• 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 a data-backed 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
• Steer and execute early stage feasibility studies, pilots, and pivotals 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

Preferred Qualifications

• Experience with on-site clinical trial support a plus
• Familiar with intellectual property development and patent assessment
• Experience working in an operating room or interventional suite environment
• Experience collaborating with physicians and collecting feedback on clinical use of the product
• Proven success recognizing critical issues and driving them to closure by taking coordinated action
• Product development and Design Controls experience