Job description

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 individual 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 individual will take an active 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. Responsibilities This position has responsibility and authority for the following: Advanced research and new product concept development • Research disease states and medical technologies associated with new business opportunities for Intuitive and applying their in-depth knowledge to become an expert 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, and others. • 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 an analytical 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. • Lead and execute early-stage feasibility, pilot, and pivotal studies 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. • 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 • 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. • Experience with on-site clinical trial support a plus. • 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 required. • Familiar with intellectual property development and patent assessment • Effective communication skills (verbal, written, presentation) • Self-starter needing minimal supervision. • Self-confident and able to react quickly under pressure. Other 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 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 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. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 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. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. 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 compensation ranges are listed.

Requirements

Must-haves

This position has responsibility and authority for the following:
Advanced research and new product concept development
Collaborate closely with engineers and physicians to define clinical performance goals and potential risks for new products in early phase development.
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 an analytical 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.
Lead and execute early-stage feasibility, pilot, and pivotal studies to support technology development for regulatory and reimbursement strategies.
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.
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
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.

Nice-to-haves

Experience with on-site clinical trial support a plus.

Application prep

Use the role’s language and application details while tailoring your materials.

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Benefits

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