Sr. Clinical Development Engineer
Intuitive Surgical, Inc., Sunnyvale, CA, United States
Position Overview
This Sr. Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, Sr. 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. This position will also allow exploration of future robotic clinical applications and solutions.
Roles and Responsibilities
Clinical and Technical knowledge
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
Observe cases and communicate assessment of robotic value and/or opportunities
Contribute expertise into clinical protocol design and strategy
Product Leadership
Participate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas
Drive frequent stakeholder alignment and solicit appropriate user feedback
Drive decision making and expedite key issues quickly
Keep the organization's vision and values at the forefront of decision making and action
Educate cross functional team on clinical workflow
Support product launches and/or clinical trials and collect early field feedback
Design Control
Conduct clinical risk analysis for new products or updates
Lead testing and clinical evaluations of new product features
Collaborate with cross functional team members including regulatory, human factors, training, engineering 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
Qualifications
Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar
Minimum of 6 years of clinical development and design control experience
Experienced in driving 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 ensure 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
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 including presentation of technical content
Ability to travel up to 25% of the time, internationally and domestic
Compensation
Base Compensation Range Region 1: $186,100 USD – $267,900 USD
Base Compensation Range Region 2: $158,200 USD – $227,700 USD
Shift: Day
Workplace Type: Onsite – This job is fully onsite.
Equal Opportunity Employer
Intuitive is an Equal 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.
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This Sr. Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, Sr. 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. This position will also allow exploration of future robotic clinical applications and solutions.
Roles and Responsibilities
Clinical and Technical knowledge
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
Observe cases and communicate assessment of robotic value and/or opportunities
Contribute expertise into clinical protocol design and strategy
Product Leadership
Participate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas
Drive frequent stakeholder alignment and solicit appropriate user feedback
Drive decision making and expedite key issues quickly
Keep the organization's vision and values at the forefront of decision making and action
Educate cross functional team on clinical workflow
Support product launches and/or clinical trials and collect early field feedback
Design Control
Conduct clinical risk analysis for new products or updates
Lead testing and clinical evaluations of new product features
Collaborate with cross functional team members including regulatory, human factors, training, engineering 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
Qualifications
Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similar
Minimum of 6 years of clinical development and design control experience
Experienced in driving 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 ensure 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
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 including presentation of technical content
Ability to travel up to 25% of the time, internationally and domestic
Compensation
Base Compensation Range Region 1: $186,100 USD – $267,900 USD
Base Compensation Range Region 2: $158,200 USD – $227,700 USD
Shift: Day
Workplace Type: Onsite – This job is fully onsite.
Equal Opportunity Employer
Intuitive is an Equal 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.
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