Intuitive Surgical Careers
Manager, Quality Engineering - Vision
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182378
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
Manages and coordinates all activities of personnel engaged in Quality Engineering focussed on Vision Products in accorance with ISI’s Quality Manual and external regulations for medical devices. Primary areas of focus include:
• Design Assurance through integration in development teams that are developing the next generation of vision products, and improvements to existing vision products. Activities include risk analysis of products and components to determine appropriate treatment of products and components based on risk. Participation in FMEA, generation of appropriate inspection plans, drawing reviews, and identification of potential challenges in process controls.• Design Transfer and New Product Introduction for vision projects as they approach manufacturing through participation and review of associated pFMEA, Equipment IQ, OQ, PQ, and process PPQ documentation.• Line support for vision products through evaluation of manufacturing defects and production non-conformances for procuct impact, disposition, and appropriate activities to support these dispositions. This position serves as the first and central escalation point for quality engineering evaluation of process and product with regard to dimensional, visual, and functional performance of components, subassemblies, and finished devices to required specifications.• Full participation as a member of the product quality management team in organizational planning, resource planning, identifying and leading quality improvement initiatives as well as participating in such initiatives led by others.
Roles and Responsibilities:
• Staff and manage the Quality Engineering team for Vision Products including staff reviews, budgeting, hiring, training, goal setting, goal tracking, correcting and rewarding.• functions to support manufacturing production goals and schedules• Build strong relationships with counterparts in Engineering, Product Teams, Production, Manufacturing Engineering, and others as appropriate.• Establish, track and report department goals• Coordinates and communicates within and across departments to address quality issues• Tracks recurring issues as needed to achieve root cause corrective action• Assure all inspection, testing and release processes are performed in accordance to procedures• Perform periodic audits to verify correct and consistent operations• Interface on a daily basis with internal customers to provide status of open issues and drive those items to closure• Develop, and report on department metrics• Develop and execute Quality Plans to support NPI transfer to sustaining manufacturing operations• Use judgment to escalate quality issues as necessary• Update process documents as necessary
• BS degree and 4 years of experience in management or managing principle position• Established project management, interpersonal and leadership skills• Technical background in micro-electronics, semiconductors (vision sensors), optics, image correction, and/or illumination.• Excellent communication skills including ability to provide written and verbal instruction in• Ability to work across team organizations and diverse cultures• Able to communicate clearly and effectively up, down, and across organizations• Must be computer literate• Proven experience and knowledge with FDA CFR 820 and ISO 13485• Working knowledge of Geometric Dimensioning and Tolerance and ability to read technical drawings• Must have a working knowledge of calibration, preventive maintenance and MRB activities• Working knowledge of quality tools: measurement repeatability systems, process control tools (Statistical Process Control)