Quality Engineer 3 - Endoluminal Systems

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 127,000 - 183,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking a Quality Engineer 3 to independently own quality projects across the Endoluminal product platform. You will manage product and process investigations, CAPA activities, and document reviews to uphold GMP/ISO/FDA standards.

The role requires at least 5 years in QE/QA with an engineering degree, strong data analysis, and collaboration across cross-functional teams. Travel is limited and the position is onsite.

Qualifications

• Minimum 5 years of experience in QE/QA and a bachelor’s degree in engineering or relevant discipline.
• Solid understanding of quality principles and methodologies.
• Strong communication, presentation and team collaboration.

Responsibilities

• Own quality projects and investigations within the Endoluminal product platform.
• Lead product/process investigations and CAPA activities.
• Review test records for completeness and accuracy and ensure compliance with GMP/ISO/FDA.

Skills

Quality engineering

Data analysis

Investigations

CAPA

Regulatory knowledge

Education

Bachelor's degree in engineering

Job description

Quality Engineer 3 - Endoluminal Systems

• Full-time
• Shift: Day
• Max. Salary Region 2: 155900 USD
• Max. Salary Region 1: 183400 USD
• Ways of Working: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type: Employee
• Min. Salary Region 1: 127400 USD
• Global Job Level (HCM): Professional 3 (9)
• Min. Salary Region 2: 108300 USD

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.

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.

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

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.

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.

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’sstart 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
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.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [e-mail].

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.