Quality Engineer 3 - SinglePort Da Vinci

Primary Function of Position:
As Intuitive’s da Vinci® Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to products in use, products in manufacturing, and products in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process.

Intuitive seeks a strong technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems. The ideal candidate possesses a broad base of experience and a high level of technical depth applicable to medical robotics and is equally at home driving continuous improvement initiatives and providing technical leadership to our team as we develop standard practices of our organization. You will not abide “process red tape”, instead passionately seek the most efficient way to build in product quality. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, and continuous improvement principles.

Roles & Responsibilities:
In general, Quality Engineering is a stakeholder and shares responsibility for: o Setting data-driven priorities for continuous improvement and ensuring quality/reliability/safety is built into Intuitive’s product design &
manufacturing by partnering with Design Engineering, Manufacturing Engineering, and Supplier Quality.
o Ensuring data quality, process quality for anything that affects Intuitive’s product or patient outcome, including the improvement of SOPs, DOPs, etc.
o Supporting deep technical failure analysis, root cause analysis, resolution, correction and prevention for challenging quality issues.
o Generating risk assessments for product in the field, including recall assessment by collaborating with compliance teams.

The main responsibilities for the individual sought by SP Product Quality are as follows.
These responsibilities are aimed at ensuring effective product introduction and production support, maintaining high quality standards, and fostering continuous improvement within the organization.
New Product Introduction and Production Support:
o Partner with manufacturing and supplier teams to effectively transfer products and processes into the production environment and provide ongoing support for these products.
o Conduct production facility validation planning, execution, and documentation, including Minimum Viable Product/Release (MVP/MVR) in Sunnyvale, CA, and assist in production transfer activities to other sites
as needed.

o Provide support for product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment.
o Offer quality engineering support for product-related issues arising from manufacturing and suppliers, manage containment, assess risks and product impacts, determine dispositions, and make escalation decisions when necessary.
o Analyze product failures and non-conformances, drive product and process improvement opportunities, conduct failure investigations, review engineering assessments, and support projects addressing these failures.
o Plan and direct the creation of quality standards, control and assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices, utilizing clinical and engineering knowledge.
o Provide expertise in change assessments (product and process) and guide other quality engineers on process validations, statistics, risk-based sampling, and measurement system analysis.
Leadership & Continuous Improvement:
o Lead and represent Product Quality at monthly and quarterly review meetings, focusing on Quality Data and Operations Review.
o Identify, present, propose, and drive continuous improvement initiatives by conducting trend analysis on reported manufacturing quality notifications and post-market complaints, and collaborate with
engineering partners.
o Assist in performing escalation assessments and driving necessary corrective and preventive actions (PIRs, CAPAs, etc.).
o Support internal and external audits, including preparation and direct interaction with auditors.
o Plan and direct the creation of quality standards, quality control and assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices, utilizing clinical and engineering knowledge.

Skills, Experience, Education, & Training:
• Good understanding of medical device company manufacturing operations and
risk-based approaches to quality
• Minimum Education: Bachelor’s degree in electrical, mechanical or system
engineering, math, or physics. Advanced degree preferred.
• Minimum 5+ years of working experience in Quality Engineering, or in
manufacturing environment; minimum 4 years in medical device design or
manufacturing environment.
• Impeccable integrity and high capacity; strong desire to make work fun
• Strong analytic skills as proven by track record for analyzing and fixing complex
problems in products and processes.
• Training or commensurate experience in the science of quality
• Proven ability to lead and motivate across functional boundaries.
• Proven ability to manage through conflicting requirements and make difficult
trade-offs when resources are scarce.
• A passion for doing the vital few, efficiently and well.
• Excellent judgment in the presence of competing priorities and incomplete data
• Understands manufacturing metrics.
• Understands basic Excel data analysis operations (e.g., Pareto, charts, and
trend).
• Working Knowledge on Tableau and Snowflake is a plus.
• Able to work in various project teams as the Quality SME.
• Able to communicate work tasks to various project team members.
• Capable of Compiling data in format appropriate for presentation.
• Travel requirement for this position is 10%.

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.

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.

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.