7 days old

Sr Project Engineer global expansion Ion

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    INSUUS213952EXTERNALENUS
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.

Roles & Responsibilities:

The NPD project engineer will initially be focused on supporting our global expansion efforts for the Ion product. You will work with project managers, regulatory and engineering personnel to help coordinate and complete all design control deliverables to support global regulatory submissions for the Ion product. You will also work on projects to expand clinical indications and device compatibility for the Ion product

  • Work with regulatory team to understand unique country specific requirements for our products
  • Work with engineering team to summarize what data is available, what additional data is required.
  • Coordinate rationales, write summary technical reports where appropriate.
  • Coordinate builds and additional testing and protocols/reports for any new requirements.
  • Interface with design engineers and tech pubs for any changes needed to design or labelling
  • Interface with the product verification team on formal verification protocols.
  • Review and update design risk analysis documents as necessary.
  • Update DHFs as required
  • Follow all design control SOPs and complete design control deliverables including requirements, risk analysis and testing.

Required Skills, Experience, Education, & Training:
  • BS Mechanical Engineering or related engineering discipline required, MS or Higher Preferred. Advanced degrees may substitute for experience
  • Minimum 8 years of experience (or 6 years with an MS degree) in a design engineering, quality engineering, or test engineering role
  • Demonstrated knowledge of design control deliverables in the product development process for catheter based devices
  • Ability to work well in a team environment
  • Excellent written and communication skills
  • Strong desire to learn, take ownership of tasks, and drive quality work

Preferred Knowledge, Skills, and Experience

  • Prior medical device development experience with flexible medical devices
  • Hands-on experience with testing medical devices
  • Experience working with and managing skilled technicians
  • Experience with electronics, particularly various sensor types and how to integrate them into test fixtures

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, 10 % of the Time





Posted: 2021-09-11 Expires: 2021-10-10
Sponsored by:
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Sponsored by:
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Sr Project Engineer global expansion Ion

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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