Manager Clinical Development Engineering

Company: Intuitive
Location: Sunnyvale
Posted on: June 16, 2022

Job Description:

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's advance the world of minimally invasive care.

Job Description

The Clinical Development Engineering team at Intuitive Surgical holds a unique position within product and procedure development by identifying clinical value through enabling the safe, effective, and reliable use of surgical robotic platforms and their components.

The Clinical Development Engineering Manager will lead a team of Clinical Development Engineers in the development of digital & data solutions that effectively augment and support robotic surgery to ultimately improve clinical outcomes for patients. The Clinical Development Engineering Manager provides leadership through thinking broadly, working cross-functionally, supporting collaboration, and building strong empowering foundations. We are looking for someone with the ability to keenly observe the surgical environment and robotic ecosystem, quickly absorb relevant information, help identify clinical needs and risks, and manage the execution of assessments and design validations to drive product development. Additionally, they recruit, develop, inspire, engage, and retain high performing clinical development engineers.

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 digital & data 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.

Roles and Responsibilities:

Digital & Data Product Development

• 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 digital & data 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 surgical digital & data products
• Collaborates with cross-functional partners, including NPD Engineering, Marketing, Clinical Affairs, Regulatory Affairs, Quality, and Project Management to develop and launch new digital & data products that enhance and support robotic surgery.
• Provides assessment of complex trade-offs, challenges, and risks with new digital & data products to the product development team to ensure broad market acceptance of new product designs.
• Contributes to the strategic plan and roadmap for future digital & data product development, working with internal and external stakeholders
• Builds strong, trusting relationships with Digital & Data business unit partners and leaders and promotes CDE opportunities for collaboration and support
• 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
  • 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
  • Communicates across all parts of the organization: training, research, design, manufacturing, quality, marketing, sales, and regulatory 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 their long-term professional development. Coaches and provides feedback on an ongoing basis
        • Provides vision for the team ensuring successful development of new digital and data 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 to improve performance
        • Influences and builds bridges across CDE and cross-functional teams and throughout the Digital & Data business unit to improve communication and processes; keeps team on target and collaborates with functional leadership to resolve conflicts quickly
        • Seeks, recognizes, and executes creative and simple solutions to resolve complex situations; routinely steadies the team when stressed; leads by example Qualifications
          
          Skill/Job Requirements:
          • Minimum Bachelor of Science degree required in Engineering or equivalent
          • Minimum 6+ years of experience in medical device product development (surgical devices preferred)
          • A leader who is a consistent high performer, a continual learner and leads with emotional intelligence
          • A team player. Experience in managing direct reports is a plus
          • 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
          • OR/Scrub experience, cadaveric, and animal surgical experience a plus
          • Ability to travel up to 25%, international and domestic Additional Information
            
            All your information will be kept confidential according to EEO guidelines.
            
            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 Employment 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.
            
            We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
            
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Keywords: Intuitive, Sunnyvale , Manager Clinical Development Engineering, Executive , Sunnyvale, California