Clinical Development Engineer

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're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

Primary Function of Position:

The Post Market Clinical Development Engineer uses their in-depth knowledge of the surgical environment and medical technology to investigate, understand, and address opportunities with products in the field work. The Post Market CDE also works with failure analysis/design engineers and clinicians to define, develop, and validate the clinical function of product improvements within our surgical robotic system platforms. They investigate and refine products including robotic systems, visualization platforms, instruments and accessories that ultimately improve the clinical outcome for patients. The primary focus of the CDE is to establish and validate data-driven clinical requirements to ensure a high-quality patient outcome.

Roles & Responsibilities:
Apply in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert within the company on the clinical application of Intuitive's products
Work with regulatory surveillance, failure analysis engineering, clinical sales representatives, and surgeons, acting as a 'detective' to assess how use scenarios contribute to findings and address root cause
Partner with Medical Safety Officer to characterize potential health hazards and feed evaluations to field action decision team
Provide a clinical voice to product development by defining and assessing clinical performance of legacy products
Collaborate closely with product engineering to define and assess products against clinical performance goals for product improvements
Use an analytical approach to identify potential product enhancements
Take an active role in sustaining engineering teams, including contributing to design reviews, and providing design guidance to engineering design teams
Assess and document clinical risks, and identify appropriate mitigations
Conduct pre-clinical testing to validate the safety and efficacy of new products
Write protocols and conduct formal validation testing for product updates and releases, and modifications to existing designs, in order to validate the clinical safety and efficacy of the product. Support FDA/regulatory documentation and applications
Provide subject matter expertise to user manual and training documentation development
Maintain current knowledge of clinical applications of Intuitive's products
Collaborate with other organizations within the company as needed, including new product development, regulatory, quality, marketing, human factors, training, and sales
Keep Intuitive's vision and values at the forefront of decision making
Perform other duties as required to support the company's overall strategy and goals

Qualifications

Skills, Experience, Education, & Training:
Minimum of B.S. in Mechanical Engineering, Biomedical Engineering, or similar, advanced degree preferred
Minimum of 5 years of experience in medical device industry with a B.S, 3 years experience with an M.S, or a PhD without experience
Experience working in Risk Management specifically in ISO 14971
Experience working with surgeons in an operating room environment
Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
Excellent analytical capability and practical skills to develop test methods and draw conclusions
Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines
Effective communication skills (verbal, written, presentation)
Proven success recognizing critical issues and driving them to closure by taking coordinated action
Self-starter needing minimal supervision
Self-confident and able to react quickly under pressure
Ability to travel up to 25% of the time, internationally and domestic

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 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 employeeswho 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'sstart 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.

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.