Intuitive
Healthcare
QualityEngineer3SinglePortDaVinci
“Quality Engineer 3 - SinglePort Da Vinci at Intuitive. Skills: Quality Engineering, medical device design or manufacturing, failure analysis, root cause analysis, risk assessments, continuous improvement. Setting data-driven priorities for continuous improvement. ensuring quality/reliability/safety is built into Intuitive’s product design & manufacturing”
Industry & Context.
solving tough engineering problems; analyzing and fixing complex problems in products and processes; solve the most technically challenging quality problems
Travel requirement for this position is 10%, proof of vaccination against certain diseases including COVID-19 may be required
What They're Looking For.
Must Have
Bachelor’s degree in electrical, mechanical or system engineering, math, or physics, 5+ years of working experience in Quality Engineering, or in manufacturing minimum 4 years in medical device design or manufacturing environment, 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, Understand manufacturing metrics, Understand basic Excel data analysis operations (e. g. , Pareto, charts, and trend)
Nice to Have
Advanced degree, Working Knowledge on Tableau and Snowflake
What You'll Do.
Setting data-driven priorities for continuous improvement
ensuring quality/reliability/safety is built into Intuitive’s product design & manufacturing
Ensuring data quality
process quality for anything that affects Intuitive’s product or patient outcome
Supporting deep technical failure analysis
correction and prevention for challenging quality issues
Generating risk assessments for product in the field
including recall assessment
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
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
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
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
and measurement system analysis
Lead and represent Product Quality at monthly and quarterly review meetings
focusing on Quality Data and Operations Review
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
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
and processes for finished devices
utilizing clinical and engineering knowledge
How You'll Work.
Team & Collaboration
partnering with Design Engineering, Manufacturing Engineering, and Supplier Quality; collaborate with engineering partners; work in various project teams
Communication Scope
Able to communicate work tasks to various project team members
Process & Methodology
lead projects to implement these initiatives
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