Senior Clinical Development Engineer - Digital Product

Intuitive•Sunnyvale, CA

3d•Onsite

About The Position

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Primary Function of Position The Senior Clinical Research Engineer in our Future Forward organization 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. They will also 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.

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.
8+ years of related experience in clinical engineering and/or product development within the medical device industry.
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.
Experience with commercial product launch.
Familiar with intellectual property development and patent assessment.

Responsibilities

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.
Develop and execute 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.
Develop and execute a preclinical evaluation strategy in advance of human trials and for regulatory submissions.
Provide subject matter expertise to user manual and training documentation development.
Support regulatory documentation and submissions.
Demonstrate an analytical approach to identify potential product enhancements and new product ideas.
Lead and execute 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.
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.