Clinical Research Engineer

Company Description

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.

Job Description

Primary Function of 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.

Essential Job Duties

The Clinical Research Engineer will:

Advanced research and new product concept development

• Research disease states and medical technologies associated with new business opportunities for Intuitive, and apply their in-depth knowledge in order to become experienced within the company on the new products being developed and their clinical application
• 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: design engineering, regulatory, human factors, industrial design, training, marketing, etc.
• Develop and execute clinical derisking pathways including both pre-clinical and clinical feasibility studies
• Contribute to market development and segmentation for new clinical applications

Clinical innovation

• Develop novel clinical models and metrics for technology evaluation and prototype performance assessment
• Develop novel procedures and workflows for new technologies
• 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

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

Required Skills and Experience

• 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, including the ability to understand complex mechanical products
• 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 to ensure timely project success
• Effective communication skills (verbal, written, presentation)
• Self-starter needing minimal supervision
• Self-assured and able to react quickly under pressure

Required Education and Training

• 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

Preferred Skills and Experience

• Experience with on-site clinical trial support a plus
• 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

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

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.