Staff Clinical Development Engineer - Endoluminal
Intuitive

Sunnyvale, California

Posted in Manufacturing and Production
about 1 month ago


This job has expired.

Job Info


At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique. 

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care.
 

Primary Function of Position:
 

This Staff Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, Staff CDE utilizes their in-depth clinical, technical and design control knowledge to collaborate with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks and identify solutions to guide product development.  They also help explore robotic clinical applications for Intuitive products, as well as opportunities to future optimize product integration into the clinical setting.
 

Roles and Responsibilities:
 

The responsibities for this position include:

  • Clinical and Technical knowledge expert
    • Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs
    • Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback
    • Clearly define clinical need and requirements for product
    • Develop test models and test methods for clinically relevant product evaluations.
    • Assess potential clinical risks and propose mitigations as an input to product design
    • Evaluate and assess clinical impact resulting from SW algorithm updates
    • Support post market investigation by driving clinical risk assessment, clinical workflow investigation and pre-clinical testing for critical field issues.
  • Product leadership
    • Drive product discovery in collaboration with product management and product design teams by being the internal champion of clinical need.
    • Lead early design investigation teams that are lean and efficient. for product enhancements & new product ideas
    • Establish milestones and success criteria for early investigations
    • Drive frequent stakeholder alignment frequently and solicit appropriate user feedback
    • Drive decision making and escalate key issues quickly
    • Keep the organization’s vision and values at the forefront of decision making and action
    • Create Best Practices guidelines, white papers
    • Mentor junior members of the team through product discovery and development
  • Design Control Expertise
    • Drive early design decisions with sound understanding of design control, clinical risks and evaluation strategy.
    • Collaborate with regulatory, human factors, training and product management to determine design and development key inputs.
    • Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders.
    • Support product launches and collect early field feedback in collaboration with product management
    • Closely collaborate with other organizations within the company, including design, marketing, regulatory, human factors, training, product management, and sales throughout product development and testing. 

Skill/Job Requirements:

  • Masters in Controls Engineering, Biomedical Engineering or similar
  • Minimum of 10 years of clinical development and design control experience
  • Experienced in driving software based product and features from concept to market
  • Ability to understand software algorithms in-depth
  • 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 leading hands-on product evaluation testing in a pre-clinical lab setting
  • Experience mentoring junior team members
  • Fluent in medical terminology and sound knowledge of anatomy
  • Self-starter needing minimal supervision
  • Self-confident and able to react quickly under pressure
  • 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
     

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 : Shift 1 - Day

Travel : Yes, 25 % of the Time

Travel Requirements: Yes, 25 % of the Time Shift: Shift 1 - Day


This job has expired.

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