Clinical Research Engineer

Intuitive • Sunnyvale, CA

283d • $150,100 - $215,900 • 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 team member 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 team member will take a dynamic 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.

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.
• 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.
• 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.

Nice To Haves

• Experience with on-site clinical trial support.
• 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.

Responsibilities

• Research disease states and medical technologies associated with new business opportunities for Intuitive.
• 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.
• 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.
• 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.

Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.

What This Job Offers

• Job Type: Full-time
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree