Quality Engineer - Endoluminal Systems

Posted 8 Days Ago
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Sunnyvale, CA, USA
Hybrid
Senior level
Healthtech • Robotics
The future of Intuitive is bright—and it will take curious, driven, and diverse team members to get us there.
The Role
Owns quality projects, investigations, inspections, CAPA, process nonconformances, risk assessments, and continuous improvement for endoluminal medical device products. Reviews test records, analyzes defect trends, maintains QMS documentation, ensures GMP, ISO, and FDA compliance, and communicates recommendations to cross-functional teams. The role also serves as an escalation owner for quality risks, participates in project core teams, and may mentor junior quality engineers.
Summary Generated by Built In
Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position

This role independently owns quality projects and initiatives, investigations, inspections and improvement activities within the Endoluminal product platform. The role will span design, manufacturing and service of a selected product or sub-system.

Essential Job Duties

  • Independently owns product, process and complaint investigations within the Endoluminal product family

  • Serves as escalation owner for low to medium impact product quality risks

  • Review and maintain test records and reports for completeness and accuracy

  • Own, drive and/or participate in CAPA and systemic Process non-conformances

  • Assist in updating and revising QMS documentation

  • Leads risk assessment activities and process reviews

  • Analyze and present data for trends in defects and report out to peers at an established cadence

  • Ensure compliance with company and regulatory standards (GMP, ISO, FDA)

  • Be an integral member of a project Core Team and contribute meaningfully to the project’s success

  • Communicate findings and recommendations to stakeholders

  • Ownership of continuous improvement projects with various levels of scope (Business Unit/Org/Team)

Breadth of Impact and Leadership

  • Owns quality outcomes for a product or defined subsystem. 

  • Recognized as a reliable QE partner by cross-functional product team. 

  • May mentor/coach junior level QEs on tools, processes and investigations.

  • Leads small initiatives

Qualifications

Required Experience and Education

  • Minimum 5 years of experience in QE/QA and bachelor’s degree in an engineering or relevant discipline, or equivalent combination of education and experience.

Required Knowledge, Skills and Abilities

  • Solid understanding of quality principles and methodologies

  • Solid data analysis and data interpretation skills

  • Identify and resolve quality issues independently

  • Strong communication, presentation and team collaboration.

  • Staying updated with evolving standards, tools and technologies

Physical Requirements

  • Travel <10%

  • Frequent computer and inspection work.

  • Occasional lifting (<25 lbs) and PPE for production or regulated areas.  

Additional Information

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 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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Skills Required

  • Minimum 5 years of experience in quality engineering or quality assurance
  • Bachelor's degree in engineering or a relevant discipline, or equivalent combination of education and experience
  • Solid understanding of quality principles and methodologies
  • Strong data analysis and data interpretation skills
  • Ability to identify and resolve quality issues independently
  • Strong communication, presentation, and team collaboration skills
  • Ability to stay updated with evolving standards, tools, and technologies

Intuitive Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Intuitive and has not been reviewed or approved by Intuitive.

  • Healthcare Strength Healthcare coverage appears broad and modern, including medical/dental/vision, telehealth, second-opinion services, fertility support, and condition-specific programs. Mental health support is positioned as strong, including access to free counseling sessions and a dedicated counseling service.
  • Wellbeing & Lifestyle Benefits Wellbeing and lifestyle offerings extend beyond core insurance, with initiatives such as vaccination clinics, fitness memberships, stress-reduction programs, and employee assistance programs. Additional lifestyle perks include curated discounts, pet insurance, identity theft prevention, and paid volunteer time.
  • Flexible Benefits Flexibility is supported through flexible work schedules and telecommuting options that can help with work-life integration. Benefit availability is described as variable by country, campus, and role, implying a menu that changes by eligibility and location.

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The Company
HQ: Sunnyvale, CA
12,000 Employees
Year Founded: 1995

What We Do

Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. 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. Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to its offerings, and develops, manufactures, and markets the da Vinci surgical system and the Ion endoluminal system.

Why Work With Us

We bring together the thinkers and doers; those who pursue excellence and are energized by discovering ways to do what can’t yet be done. We question, we test, we challenge each other and the status quo until we see the impact we’ve made, until we’ve set a new standard for minimally invasive care. We revel momentarily in our achievements before sta

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