Manager, Clinical Development Engineering

Intuitive•Sunnyvale, CA

About The Position

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.

Requirements

8+ years of experience in medical device product development (surgical devices preferred) and 1-3 years of management responsibilities through technical leadership, project management, or people leader role
A leader who is a consistent high performer, a continual learner and leads with emotional intelligence
A team player
Self-starter with ability to take leadership in a fast-paced and dynamic environment
Experience interacting with surgeons and their teams in an operating room environment with recognized clinical credibility and surgical acumen.
Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
Aptitude to cultivate collaboration with Key Opinion Leaders and influence cross-functional teams without formal authority to ensure project success
Proven success in recognizing critical issues with the ability to react quickly under pressure and driving issues to closure by providing coordinated direction.
Creative in succeeding
Strong project management, planning, decision making, negotiating and change management skills
Excellent communication skills (verbal, written, presentation) and experience conveying complex ideas to others
Minimum Bachelor of Science degree required in Engineering or equivalent
Ability to travel up to 25% of the time, internationally and domestic
For positions related to development of the optical/vision system, the ability to have near and far visual acuity (clarity between 12 inches and 20 feet with or without corrective lenses), stereoscopy, and the ability to see all colors is required.

Nice To Haves

Current or previous experience as an Intuitive Clinical Development Engineer preferred
Experience in managing direct reports is a plus
OR/Scrub experience, cadaveric, and animal surgical experience a plus

Responsibilities

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
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
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