CDE Manager

Company: Intuitive
Location: Sunnyvale
Posted on: May 13, 2022

Job Description:

Company DescriptionAt 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 theirmost 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 DescriptionPrimary Function of Position:This Clinical Development Engineering (CDE) Manager role will recruit, develop, inspire, engage, and retain high performing clinical development engineers. In this position, the CDE Manager utilizes their in-depth clinical, technical, design control knowledge and people leadership skills to lead a team that drives collaboration with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms.Roles and Responsibilities:The responsibilities for this position include:

• Management
  • Leads a team of high-performing Clinical Development Engineers including hiring, training, and coaching them on an ongoing basis to support their professional development
  • Identifies and drives quarterly and yearly team goals that align with business goals
  • Supports business needs through resource planning and identifying key resource gaps in advance
  • Empowers the team to lead, problem solve and use creativity
  • Drives collaboration across cross-functional team and functional leadership
  • Keeps the organization's vision, values, strategy, and goals at the forefront of decision making and action
  • Product Development
    • Provides strategic clinical input to inform product discovery in collaboration with product management and product design teams
    • Facilitates key trade-off assessment and prioritization, establishes metrics and tracks progress on various projects
    • Provides sound technical and clinical decisions with limited information; consults key stakeholders, synthesizes and anticipates impact of actions
    • Articulates process improvements that accelerate or strengthen product development processes and results
    • Guides the team in driving appropriate risk assessment and validation strategy for the product, selection of appropriate pre-clinical models for evaluation and design trade-offs considerations
    • Supports the team in driving early-stage product investigations including investigating clinical literature, gathering physician feedback, exploring key clinical needs and associated risksQualificationsSkill/Job Requirements:
      • Masters in Controls Engineering, Biomedical Engineering, Mechanical Engineering or similar
      • Minimum of 6 years of medical device product development experience
      • Minimum 2 years of experience in managing personnel
      • A leader who is a consistent high performer, a continual learner and leads with emotional intelligence
      • Experience driving software-based products and features from concept to market
      • Experience collaborating with physicians and collecting feedback on clinical use of the product
      • Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to insure project success
      • Experience understanding clinical harms and performing clinical risk analysis
      • Experience developing design validation strategy, protocol creation and testing
      • Experience with pre-clinical models
      • Experience mentoring and developing junior team members or direct reports
      • Fluent in medical terminology and sound knowledge of anatomy
      • Self-starter and passionate about addressing the key clinical needs -
      • Proven success in recognizing critical issues with the ability to react quickly under pressure and driving issues to closure by providing coordinated direction
      • Strong project management, planning, decision making, negotiating and change management skills
      • Ability to adapt priorities in a fast-paced, dynamic, product development team
      • Excellent verbal and written communications skills required including presentation of technical content
      • Ability to travel up to 25% of the time, internationally and domestic#911Additional InformationDue 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.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. Shift : Day Travel : 25% of the timeTravel Requirements:25% of the time Shift:Day

Keywords: Intuitive, Sunnyvale , CDE Manager, Executive , Sunnyvale, California