Quality Engineer Endoluminal Systems

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 projects 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 bachelors 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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time