Job Description Primary Function of Position As Intuitive’s da Vinci® Surgical System and other medical devices become 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 product in use, product in manufacturing, and product 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 review and process escalation activities, review, and update risk management file documents, and identify key opportunities for product improvement. You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality. Essential Job Duties 90% Risk Management document support, 10% quality advocacy and project management. Risk Management Participate in Risk Analyses for new and existing products, including review of both hardware and software. Using data from Post Market reviews, update risk documentation as needed, following confirmations with Project QEs and Design Engineering. Work with Design Engineering to maintain tracing of risk to requirement to test. Work with Manufacturing Engineering on process risk documents Participate in review of technical and quality information for regulatory submissions. Quality Process Improvements As needed, participate in Quality process improvement projects (CAPA, Process NonConformance, Quality Plans, other process improvements) #J-18808-Ljbffr
Risk Management Engineer 3
INTUITIVE
mexicali, mexicali
Publicado hace 24 días
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