Manager, Clinical Development Engineering

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.

• 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

• 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 their long-term professional development. Coaches and provides feedback on an ongoing basis
  • Provides vision for the team ensuring successful development of new products and solutions. Fosters an environment that encourages creativity and crisp execution and recognizes achievements, contributions, and learning
  • Develops methodology and encourages team members to use accurate data and appropriate judgment to form decisions
  • Establishes sub-team objectives and work goals consistent with overall departmental and project goals.
  • Facilitates alignment of priorities, reviews metrics and tracks progress
  • Assesses employee performance and provides coaching
  • Influences and builds bridges across CDE and cross-functional teams and throughout the BU to improve communication and processes; keeps team on target and collaborates with functional leadership to resolve conflicts and address needs quickly
• Seeks, recognizes, and executes creative and simple solutions to resolve complex situations; routinely steadies the team when stressed; leads by example