Quality Engineer 3 - SinglePort Da Vinci

Intuitive•Sunnyvale, CA

About The 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.

Requirements

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.
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).
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.

Nice To Haves

Advanced degree preferred.
Working Knowledge on Tableau and Snowflake is a plus.

Responsibilities

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.
Ensuring data quality, process quality for anything that affects Intuitive’s product or patient outcome, including the improvement of SOPs, DOPs, etc.
Supporting deep technical failure analysis, root cause analysis, resolution, correction and prevention for challenging quality issues.
Generating risk assessments for product in the in-field, including recall assessment by collaborating with compliance teams.
Partner with manufacturing and supplier teams to effectively transfer products and processes into the production environment and provide ongoing support for these products.
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.
Provide support for product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment.
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.
Analyze product failures and non-conformances, drive product and process improvement opportunities, conduct failure investigations, review engineering assessments, and support projects addressing these failures.
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.
Provide expertise in change assessments (product and process) and guide other quality engineers on process validations, statistics, risk-based sampling, and measurement system analysis.
Lead and represent Product Quality at monthly and quarterly review meetings, focusing on Quality Data and Operations Review.
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.
Assist in performing escalation assessments and driving necessary corrective and preventive actions (PIRs, CAPAs, etc.).
Support internal and external audits, including preparation and direct interaction with auditors.
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.