Job description

Primary Function of Position The Senior Clinical Research Engineer, Future Forward, 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. The Senior Clinical Research Engineer will 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. This individual will develop and execute pre-clinical experimental strategies to evaluate device performance, safety, and usability through the Product Development Process (PDP) ensuring readiness for commerical launch. The Senior Clinical Research Engineer will also work with cross-functional teams—including regulatory, quality, clinical affairs, and finance—to shape clinical indications and commercialization strategies, driving the technology from concept to a commercial-ready product. Essential Job Duties The Senior Clinical Research Engineer will: Pre-clinical research and commercial concept development: • Lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise. • 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. Clinical research and innovation: • 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. Others: • 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. Required Skills and Experience • 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. Required Education and Training • 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. Working Conditions • Must be available to work full-time and commute/relocate to Sunnyvale, CA. • Up to 30% travel. Some international travel will be required. • Primary Location: Sunnyvale, CA. Preferred Skills and Experience • Experience with on-site clinical trial support a plus. • Experience with commerical product launch a plus. • Familiar with intellectual property development and patent assessment 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. Accommodation & Accessibility Notice: Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com. 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

Primary Function of Position
Essential Job Duties
Pre-clinical research and commercial concept development:
Lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical, scientific, and technical expertise.
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.

Nice-to-haves

Preferred Skills and Experience
Experience with on-site clinical trial support a plus.
Experience with commerical product launch a plus.

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