Senior Clinical Research Engineer, System

Company Description

At Intuitive, we firmly stand by our mission: we believe that minimally invasive care is life-enhancing care. Through innovation and intelligent technology, we expand the reach of physicians to heal without restrictions.

Being a pioneer and market leader in robotic-assisted surgery, we aim to encourage a diverse and inclusive team, dedicated to making a difference. For over 25 years, we have been partnering with hospitals and care teams globally to help solve some of healthcare's toughest challenges and advance possibilities.

Intuitive has been shaped by the efforts of brilliant individuals from diverse backgrounds. We believe great ideas can come from anywhere. We make a conscious effort to promote a culture that values diversity of thought and mutual respect. We lead with inclusivity and empower our team members to do their best work as their most authentic selves.

Our culture is driven by passionate individuals who aim to make a difference. Our team members are ethical, possess a strong ability to learn, the vitality to achieve goals, and bring a diversity of real-world experiences to inspire new thinking. We actively invest in our team to support their long-term growth so they can continuously contribute to our mission and achieve their highest potential.

Join a team committed to taking significant strides for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Role of the Position
The Sr. Clinical Research Engineer uses their extensive clinical, scientific, and technical knowledge to work in partnership with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts at early exploration stages. The individual brings their clinical device development expertise to the 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 Sr. Clinical Research Engineer is responsible for developing and executing an experimental strategy to assess the performance and safety of prototype designs and is a significant contributor in the design and development iteration process. The individual will play an active role in the concept design team by evaluating 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 like regulatory, clinical affairs, finance, etc., to develop the clinical indication and commercialization strategy.
Responsibilities

This position has responsibility and authority for the following:

Advanced research and new product concept development

• Research disease states and medical technologies connected with new business opportunities for Intuitive, applying their 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 thought leaders, subject matter experts, physicians, and other stakeholders to identify clinical goals and reinterpret these needs for user-centered design and development of new platforms, procedures, instruments, and accessories
• Partner with other departments within the company as needed, leading the clinical aspects of new programs and platform development, such as design engineering, regulatory, human factors, industrial design, training, marketing, etc.
• Develop and execute clinical de-risking pathways, including pre-clinical and clinical feasibility studies
• Contribute to market development and segmentation for new clinical applications

Clinical innovation

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

Other tasks

• Keep the organization's vision and values on top 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 8+ years of related experience in clinical engineering and/or product development within the medical device industry
• Proficiency in medical procedure terminology and good knowledge of anatomy
• Able to understand complex robotic systems and software algorithms
• Experience working in an operating room or interventional suite environment
• Experience working with physicians and collecting feedback on clinical product use
• Experience with on-site clinical trial support is a plus
• Outstanding mechanical and technical aptitude, and intuition for spatial relations, specifically the ability to comprehend complex mechanical products
• Excellent analytical skills and hands-on experience to develop and test a clinical hypothesis and draw succinct conclusions
• Excellent teamwork skills with a proven track record of fostering collaboration across multiple disciplines to ensure timely project success
• Proven success in identifying critical issues and driving them to resolution through coordinated action
• Product development and Design Controls experience required
• Familiarity with intellectual property development and patent assessment
• Effective communication skills (verbal, written, presentation)
• Self-starter needing minimal supervision
• Self-confident and can react quickly under pressure

Job Requirements:

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

Additional Information