Senior Clinical Research Engineer

Job description

The Sr CRE 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.

The Managing CRE is a technical individual that has aptitude and desire to expand into people management.

Responsibilities

Advanced research lead and new product concept development

• Identify key clinical needs for novel instrumentation, systems and devices Primary architect of clinical requirements, clinical risks and mitigations
• Participates on researching 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. Monitors and advices complex technical and clinical aspects of the product. Hire, develop and mentor a small group of CREs for the program. 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. 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. Perform other duties as required to support the company's overall strategy and goals.

Qualifications

Required Education, Skills & Experience Minimum of a M.S. or PhD in Biomedical Engineering, Mechanical Engineering, or similar field with interest to expand into people management. Minimum of 5 years of related experience in clinical engineering and/or product development within the medical device industry. Product development and Design Controls experience. 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 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. Effective communication skills (verbal, written, presentation). Self-starter needing minimal supervision.

Preferred Skills & Experience

Medical Robotics experience highly desirable Experience with clinical procedures for MIS General Surgeries, Spine Surgeries, Orthopedic, and adjacent procedures Experience with Visualization, Ultrasound Guidance , Energy Instrumentation, Medical Surgical Instrumentations, Pre Treatment MRI and CT planning Experience working in an operating room. Experience collaborating with physicians and collecting feedback on clinical use of the product.

Experience with on-site clinical trial support.