Clinical Development Engineer (Finance)

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 us advance the world of minimally invasive care.
Job Description
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

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.

Base Salary Range Region 1: $150,100 USD - $215,900 USD
Base Salary Range Region 2: $127,600 USD - $183,600 USD
Shift: Day
Workplace Type: Onsite - This job is fully onsite.