Quality Engineer - Endoluminal Systems

Socket.dev; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical is seeking a Quality Engineer to independently own quality projects across Endoluminal product platforms. You will drive investigations, CAPA activities, and improvement initiatives while ensuring GMP/ISO/FDA compliance within design, manufacturing and service contexts.

Ideal candidates have 5+ years in QE/QA with a bachelor’s degree in engineering, strong data analysis skills, and excellent communication to collaborate with cross-functional teams that include developers,

Qualifications

• Solid understanding of quality principles and methodologies.
• Strong 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.

Responsibilities

• Independently owns quality projects, investigations and CAPA activities.
• Serves as escalation owner for product quality risks.
• Review and maintain test records and reports for accuracy.
• Lead risk assessments and process reviews.
• Communicate findings and recommendations to stakeholders.
• Own continuous improvement initiatives across scope levels.

Skills

Quality principles

Data analysis

Independent issue resolution

Communication & collaboration

Regulatory awareness

Education

Bachelor's degree in engineering

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

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.

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 onbusiness 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 thecandidate’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.

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.