9 days old

Clinical Development Engineer (All Levels - CDE - Senior CDE - Staff CDE)

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    220333
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
Roles and Responsibilities:

  • Understand and represent the voice of surgeons and clinical OR staff through hands-on testing of products in a simulated surgical environment
    • Develop surgical expertise by applying in-depth knowledge of surgical procedures, operating room environment, and da Vinci surgical systems in lab
    • Collaborate with marketing partners and clinicians to identify enhancements that meet clinical needs
  • Bring new products and product changes to market as part of the cross-functional project team by assessing device performance and influencing design
    • Establish clinical performance requirements and inform design specifications for safe and effective products
    • Conduct assessments of the clinical performance of prototype designs and provide feedback to the design engineering team on areas for improvement
    • Write protocols and conduct testing in a simulated surgical environment to formally validate the safety and efficacy of new or updated products as part of the design controls process
  • Perform and document clinical risk assessments to identify risks associated with using the device and their mitigations
  • Serve as clinical subject matter expert
    • Support regulatory documentation and submissions
    • Provide expertise to user manual and training development
Qualifications
Skills, Experience, Education & Training:

Requirements:

  • Minimum of B.S. in Mechanical Engineering, Biomedical Engineering, or similar
  • Minimum of 2 years of experience in medical device industry with level at hiring (Senior or Staff CDE) to be based on education and experience
  • Passion for hands-on lab-based work, including ex-vivo, in-vivo, and in-vitro models
  • Aptitude for distilling complex information into key concepts to communicate across both internal engineering and external medical audiences
  • Excellent ability to design robust experiments with sound test methods, perform data analysis, and draw data-driven conclusions
  • Collaborative approach to facilitate building relationships across multiple disciplines as part of a project team
  • Experienced in recognizing and troubleshooting issues, - from clinical safety to usability, - and driving execution of solutions and risk mitigations
  • Strong written communication skills and attention to detail to support regulatory submissions
  • Self-starter needing minimal supervision
  • Ability to travel up to 15% of the time, internationally and domestic

Preferences:
  • MD, MS or PhD in Mechanical Engineering, Biomedical Engineering, or similar
  • Extensive experience working with surgeons in an operating room environment
  • Fluent in surgical terminology with sound knowledge of anatomy and surgical technique

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.
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.

Shift : Day

Travel : 25% of the time





Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Sponsored by:
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Clinical Development Engineer (All Levels - CDE - Senior CDE - Staff CDE)

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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