Posted 25 days ago

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 highly skilled manufacturing engineer will support multiple manufacturing lines for both mature and new instruments, accessories, and endoscopes for the Ion platform.  This engineer must be able to develop new and improved manufacturing processes, and keep existing manufacturing lines running smoothly by collaborating across functions to solve a wide variety of technical process and equipment problems.  This person will support manufacturing in Sunnyvale, CA, in-person, Monday through Thursday from 2pm to 1am.

 

Roles and Responsibilities:

  • Support several Ion manufacturing lines including:
    • Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
    • Manage product reliability improvements from concept to implementation
    • Identify, design, qualify, document and introduce assembly/test fixtures and equipment
    • Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety
    • Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans
    • Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementations
    • Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders
    • Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
    • Provide technical support for failure analyses and root cause investigations of product failures
  • Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress
  • Provide resource budget estimates for product and process improvements, tooling development, and testing
  • Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements
Skill/Job Requirements:
  • Minimum B.S. degree in engineering discipline, M.S. preferred
  • Prior responsibility for process and equipment validations
  • Strong technical & analytical skills, background in material bonding, catheters, and vision-related products is a plus
  • Prior experience working with plastic manufacturing and bonding processes preferred (injection molding, extrusion, reflowing, laminating, etc.)
  • Familiar with mechanical CAD software (SolidWorks)
  • Strong organizational skills and proven ability to work on several fast-paced projects simultaneously
  • Prior experience with managing product and process changes
  • Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus
  • Able to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers
  • Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus
  • Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus

 

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 : Shift 1 - Day

Travel : Yes, 10 % of the Time

Mission
We're a community of women leveraging our connections into top companies to help underrepresented women get the roles they've always deserved. Simultaneously, we work to build truly inclusive hiring processes and environments where women can thrive and not just survive.
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Manufacturing Engineer - Medical Instruments and Endoscopes