Quality Engineer 3 - Endoluminal Systems
Intuitive
Summary
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.
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
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.
Requirements
- Minimum 5 years of experience in QE/QA
- Bachelor's degree in an engineering or relevant discipline, or equivalent combination of education and experience
- 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
Benefits
- Market-competitive compensation
- Base pay plus incentives
- Benefits
- Equity
Company overview
Intuitive Surgical, Inc., commonly known as Intuitive, is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. Founded in 1995 and headquartered in Sunnyvale, California, the company has revolutionized surgical procedures through its flagship da Vinci Surgical System and Ion endoluminal system. As a publicly traded company on NASDAQ (ISRG), Intuitive has established itself as the dominant player in robotic surgery, with over 15,000 employees worldwide and an installed base of thousands of surgical systems across more than 60 countries. The company's innovative platforms enable surgeons to perform complex procedures with enhanced precision, flexibility, and control through minimally invasive techniques. Intuitive's technology portfolio includes advanced vision systems, wristed instruments, and intelligent software that work together to optimize surgical outcomes. The company continues to expand its product offerings and geographic presence while maintaining a strong focus on clinical evidence, physician training, and patient safety. With annual revenues exceeding $8 billion, Intuitive represents a transformative force in modern healthcare, driving the adoption of robotic-assisted procedures across multiple surgical specialties including urology, gynecology, general surgery, and thoracic surgery.