Manager, Clinical Development Engineering

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 Clinical Development Engineering (CDE) Manager leads a team and uses their in-depth knowledge of the Da Vinci Surgical Systems and surgical workflows to work with clinicians and cross-functional partners to develop safe and highly effective MP Platform products. The CDE Manager is responsible for establishing data-driven clinical requirements, the validation of new products to ensure high-quality patient outcomes, and for conveying clinical value throughout the organization. The team focus will be primary support for System/Software development projects while working in concert with MP technology development partners (including instruments & accessories, energy, stapling, and vision) and MP surgical procedure development partners.  From a management focus, the CDE manager will serve as the liaison and lead contact with the MP business unit for the CDE department, taking a business-centric view of all MP programs and projects.

Roles and Responsibilities:

Product Development

• Manages clinical development engineering activities and resources related to new product development:
  • Developing clinical product requirements and performance goals
  • Assessing and documenting clinical risks and mitigations and advising engineering regarding risks and mitigations
  • Providing clinical guidance to engineering product design teams
  • Performing informal assessments of the clinical performance of prototype designs
  • Creating and executing formal clinical validations of final product designs
  • Supporting first human use and/or launch of new products
• Understands the clinical needs of surgeon and OR team and monitors the progression of state-of-the-art surgical technique and technologies to help define products that provide clinical value for the patient and are technically feasible.
• Works with cross-functional partners, internal SMEs and surgeons, and external KOLs to identify the clinical value and potential market opportunity of new Da Vinci MP systems and surgical products.
• Collaborates with cross-functional partners, including Engineering, Marketing, Clinical Affairs, Regulatory Affairs, Quality, and Project Management to develop and launch new products that enhance and support robotic surgery.
• Provides assessment of complex trade-offs, challenges, and risks with products to the product development team to ensure broad market acceptance of new product designs.
• Contributes to the strategic plan and roadmap for future product development, working with internal and external stakeholders.
• Articulates and promotes process improvements that accelerate or strengthen product development processes and results.
• Supports strategic planning and creation of regulatory submissions and first human use of product
• Works with cross-functional user facing teams (HF, IxD, marketing/sales) to identify and collaborate with key opinion leaders and together provide a unified “voice of the customer”
• Works with upstream colleagues to identify product enhancements and influence new ideas by leading data driven clinical evaluations and research
• Works with downstream colleagues to support clinical trials for our products and their applications, establish best practices, and validate marketing claims

Management

• Organization:
  • Keeps the organization’s vision, values, strategy, and goals at the forefront of decision making and action
  • Consistently demonstrates culture and values of the organization internally and externally
• Team:
  • Hires, trains, and develops high performing staff, and supports