Clinical Research Engineer

Intuitive•Sunnyvale, CA

15h•Onsite

About The Position

Primary Function of Position The Clinical Research Engineer, Future Forward, will lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise. This individual will collaborate closely with engineers, physicians, interaction designers, human factors, training and technical publication specialists, and various internal and external stakeholders to guide product and procedure development. The Clinical Research Engineer will play a key role in proctoring early-stage feasibility clinical studies, gathering case insights to support technology advancement, identifying and documenting user needs, managing product requirements, assessing clinical risks, and providing design guidance for clinical and commercial design and development. This individual will develop and execute pre-clinical experimental strategies to evaluate device performance, safety, and usability through the Product Development Process (PDP) ensuring readiness for commerical launch. The Clinical Research Engineer will also work with cross-functional teams—including regulatory, quality, clinical affairs, and finance—to shape clinical indications and commercialization strategies, driving the technology from concept to a commercial-ready product.

Requirements

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.
Effective communication skills (verbal, written, presentation).
Self-starter needing minimal supervision.
Self-confident and able to react quickly under pressure.
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 or a Master with 3+ years of related experience
Must be available to work full-time and commute/relocate to Sunnyvale, CA.
Up to 30% travel.
Some international travel will be required.

Nice To Haves

Experience with on-site clinical trial support a plus.
Experience with commerical product launch a plus.
Familiar with intellectual property development and patent assessment

Responsibilities

Pre-clinical research and commercial concept development: Contribute to design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise.
Research disease states and medical technologies associated with new business opportunities to become an expert on new products and their clinical applications.
Collaborate with marketing partners and clinicians to identify and understand marketing needs.
Work with key opinion leaders, subject matter experts, and other stakeholders to identify clinical goals and translate those needs into user-centric designs for new platforms, procedures, instruments, and accessories.
Collaborate closely with engineers and physicians to define and evaluate clinical performance goals, potential safety and usability risks for new products in early-phase development.
Contribute to development and execution of clinical derisking pathways, including pre-clinical and clinical feasibility studies, to ensure technology advancement and readiness for commercial launch.
Conduct design iteration assessments of products both internally and with external key opinion leaders.
Contribute to development and execution of preclinical evaluation strategy in advance of human trials and for regulatory submissions.
Provide subject matter expertise to user manual and training documentation development.
Help support regulatory documentation and submissions.
Demonstrate an analytical approach to identify potential product enhancements and new product ideas.
Clinical research and innovation: Contribute to the development and execution of early-stage feasibility clinical studies, pilot and pivotal clinical trials to support technology development for regulatory and reimbursement strategies.
Identify and drive product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users.
Collect and analyze clinical study insights to inform new product requirements, training needs, manage clinical risks adhering to quality management systems.
Design, develop, and execute clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration.
Develop intellectual property for novel clinical applications and technologies.
Others: 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.