Senior Clinical Research Engineer

Company Description

At Intuitive, we are driven by our mission: we believe that minimally invasive care is life-enhancing care. Through innovation and smart technology, we empower physicians to heal without constraints. As a pioneering and market leader in robotic-assisted surgery, we strive to nurture a diverse and inclusive team who are committed to making a difference. For over a quarter of a century, we have partnered with hospitals and care teams globally to address some of healthcare's toughest challenges and to push the boundaries of what is achievable. Intuitive has been built by the hard work of extraordinary people from varied backgrounds. We believe that great ideas can emerge from anywhere. We aim to cultivate an inclusive culture that values diversity of thoughts and mutual respect. We lead with inclusion and empower our team members to excel in their roles as their most authentic selves. Our culture is driven by passionate individuals who desire to make a difference. Our team members are rooted in integrity, possess a strong capacity to learn, possess the energy to make things happen, and bring diverse, real-world experiences that help us think differently. We actively invest in our team members to support their long-term growth so they can continue to drive our mission and reach their maximum potential. Join a team committed to making significant strides for a worldwide community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of the Position
The Sr. Clinical Research Engineer leverages their extensive clinical, scientific, and technical knowledge to collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop fresh product concepts being incubated in early exploration. This individual employs their clinical device development expertise to new platform and technology development and is in charge of identifying, documenting, and understanding user needs, and subsequently communicating these needs to inform concept design and development.  The Sr. Clinical Research Engineer is responsible for developing and executing an experimental strategy to assess the performance and safety of prototype designs and plays a crucial role in the design and development iteration process. This individual is actively involved 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 works closely with team members such as regulatory, clinical affairs, finance, and more to shape the clinical indication and commercialization strategy.
Responsibilities

This position is responsible for the following:

Advanced research and new product concept development

• Research disease states and medical technologies linked to new business opportunities for Intuitive, and apply comprehensive knowledge to become a company expert on the new products being developed and their clinical application
• Work 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 to lead the clinical aspects of new programs and platform development: design engineering, regulatory, human factors, industrial design, training, marketing, etc.
• Develop and execute clinical de-risking pathways including both pre-clinical and clinical feasibility studies
• Contribute to market development and segmentation for new clinical applications

Clinical innovation

• Create innovative clinical models and metrics for technology evaluation and prototype performance assessment
• Develop innovative procedures and workflows for new technologies
• Design, develop, and carry out clinical evaluations of prototypes with the ability to translate feedback to the engineering team for technology acceleration
• Perform design iteration assessments of products both internally and with external key opinion leaders
• Identify and drive product enhancements and new product ideas by using an analytical approach to understanding the clinical needs of physicians and users
• Formulate and execute a preclinical evaluation strategy ahead of human trials and for regulatory submissions
• Lead and carry out early stage feasibility studies, pilots, and pivotal to support technology development for regulatory and reimbursement strategies
• Develop intellectual property for novel clinical applications and technologies

Other

• 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

Qualifications

Preferred Qualifications

• Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or similar
• Minimum of 8+ years of relevant experience in clinical engineering and/or product development within the medical device industry
• Fluency in medical procedure terminology and a solid understanding 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
• Experience with on-site clinical trial support is a plus
• Excellent mechanical and technical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products
• Excellent analytical ability and practical skills to develop and test a clinical hypothesis and draw concise conclusions
• Excellent teamwork skills with a proven ability to foster collaboration across multiple disciplines to ensure timely project success
• Proven success in identifying critical issues and driving them to closure by taking coordinated action
• Product development and Design Controls experience is required
• Familiarity with intellectual property development and patent assessment
• Effective communication skills (verbal, written, presentation)
• Self-starter needing minimal supervision
• Self-confident and able to handle pressure effectively

Job Requirements: 

• Must be available to work full-time and willing to commute/relocate to Sunnyvale, CA
• Up to 25% travel. Some international travel may be required.
• Primary Location: Sunnyvale, CA

Additional Information