Clinical Research Engineer - Future Forward

Intuitive; Sunnyvale (CA); On-site; USD 155,300 - 223,500; Full time

Job summary

Intuitive in Sunnyvale, CA is seeking a Clinical Research Engineer to leverage clinical knowledge in product development. This role includes collaborating with engineers and physicians, assessing prototypes, and ensuring safety in device development.

The ideal candidate has a degree in Biomedical or Mechanical Engineering, significant experience in clinical environments, and strong analytical skills. The position requires full-time presence in Sunnyvale and may involve up to 25% travel.

Qualifications

• 5+ years in clinical engineering or product development.
• Experience in operating room or similar environments.
• Familiar with robotic systems and medical terminology.

Responsibilities

• Collaborate with engineers and physicians on product development.
• Conduct clinical evaluations and user feedback assessments.
• Lead pre-clinical assessment strategies and market development.

Skills

Clinical engineering

Product development

Mechanical aptitude

Analytical skills

Communication skills

Education

B.S. in Biomedical Engineering or Mechanical Engineering

Job description

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic‑assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide. We are a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human.

Job Description

The Clinical Research Engineer uses in‑depth clinical, scientific, and technical knowledge to collaborate with engineers, physicians, user experience researchers, and other stakeholders to develop new product concepts being incubated in early exploration. The role requires clinical device development expertise, identifying and documenting user needs, and communicating these needs to inform concept design and development. The engineer develops and executes experimental strategies to assess performance and safety of prototype designs and is a key contributor in the design and development iteration process. Responsibilities also include assessing clinical risks, providing design guidance, inventing new concepts, and partnering with regulatory, clinical affairs, finance, and more to develop the clinical indication and commercialization strategy.

Responsibilities

Advanced Research and New Product Concept Development

• Research disease states and medical technologies related to new business opportunities for Intuitive and become an expert on the new products 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 into 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 pre‑clinical 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.

Qualifications

• Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or a similar field.
• 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.

Additional Information

Due to the nature of our business and the role, you may be required to provide current proof of vaccination against certain diseases including COVID‑19. Details may vary by role.

Equal Employment Opportunity

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.

Export Controls

• 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. For any role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed Technology Control Plan before the prospective employee’s start date.

Compensation

Base Salary Range Region 1: $155,300 – $223,500.

Base Salary Range Region 2: $132,000 – $190,000.

Shift: Day. Workplace Type: Onsite – this job is fully onsite.