Intuitive Surgical Careers
Senior Manager, Clinical Development Engineering
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182818
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Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
Embedded in the Multi-Port Product Development Department the Senior Manager, Clinical Development Engineering will lead a team of Clinical Development Engineers in the development of highly effective robotic systems, instruments and accessories that ultimately improve the clinical outcome for patients. The Senior Manager, Clinical Development Engineering provides leadership through in-depth knowledge of the surgical application da Vinci® Surgical System. Additionally, they recruit, develop, and retain high performing clinical engineers.
Furthermore this position serves as a clinical consultant regarding prospective design improvements based on clinical experiences, as well as monitor the progression of the state-of-the-art surgical technique so as to influence the trajectory of product innovation accordingly.
Roles and Responsibilities:
• As the clinical leader of the da Vinci® Surgical System and EndoWrist® Instrumentation in the operating room environment identifies prospective product enhancements & new ideas by applying an analytical approach.
• Understands the clinical needs of surgeons and monitors the progression of the state-of-the-art surgical technique to define products that provide clinical value for the patient and that are technically feasible.
• Provides assessment of complex trade-offs and risks with new products to Product Development team to ensure broad market acceptance of new product designs.
• Articulates process improvements that accelerate or strengthen product development processes and results.
• Manages the upstream marketing and product validation phases of the product development lifecycle for the da Vinci® Surgical System and EndoWrist® instrumentation
• Manage the clinical development engineering activities and resources related to new product development:
• developing clinical product requirements
• assessing and documenting clinical risks
• providing design 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
• Manages the clinical development engineering activities and resources for continuing engineering projects related to the existing da Vinci® Surgical System platforms and EndoWrist® Instrumentation
• Manages clinical evaluation of new or enhanced products at key customer sites
• Work with product management and product marketing to conduct product-specific “focus group” meetings with key customers at scientific conferences
• Supports Clinical Affairs in conducting clinical trials for new product/da Vinci application approval
• Support regulatory in the strategic planning of regulatory submissions and responses to FDA questions
• Keeps the organization’s vision and values at the forefront of decision making and action
• Hires, trains and develops high performing staff, and supports their long term professional development
• Manage resources to budget and project priorities
• Provides vision for team ensuring successful adoption of the Intuitive Surgical products in clinical use. The leader of this function must provide an environment that encourages creativity, and crisp execution.
• Performs other duties as required to support the company's overall strategy and goals
• Develops methodology and encourages team members to use accurate data and appropriate judgment to form decisions
• Consistently demonstrates culture and values of the organization internally and externally
• Establish sub-team objectives and work goals consistent with overall and product/surgical application development goals
o Facilitates priority alignment, review metrics and track progress
o Assesses employee performance and provides coaching to improve performance
o Influences and builds bridges across teams to improve communication and processes; keeps team on target and collaborates with functional leadership to resolve conflicts quickly
o Seeks, recognizes, and executes creative and simple solutions to resolve complex situations; routinely steadies the team when stressed; leads by example
• Minimum B.S. Degree in Biomedical Engineering or Mechanical Engineering required
• Minimum 3 years of surgical experience with da Vinci systems in a clinical environment preferred
• Minimum 8 years of experience in medical product development (surgical devices preferred)
• An experienced leader who is a consistent high performer, a continual learner and leads with emotional intelligence
• Ability to travel up to 40%, international and domestic
• Experience working with surgeons and their teams in an operating room environment and proven clinical credibility
• Aptitude to cultivate collaboration across Key Opinion Leaders and influence cross-functional teams without formal authority to insure project success
• Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction. Creative in succeeding.
• Must be fluent in surgical terminology and have sound knowledge of anatomy/surgery
• Scrub experience a plus
• Excellent communication (written, verbal), presentation and documentation skills
• Strong project management, planning, decision making, negotiating and change management skills
• Need strong mechanical aptitude with thorough spatial cognition and understanding of 3D orthogonal mechanics as they relate to robotic/laparoscopic surgery
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.