Quality Engineer 3
2 months ago
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 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. The position will support manufacturing of systems for the Da Vinci Multiport business unit.
Roles & Responsibilities:
- Initial roles and responsibilities for this position will include the following: 60% involvement in supporting sustaining manufacturing operations, 25% design controls and 15% quality advocacy (quality improvements)
- Manufacturing support: Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments
- Ensure manufacturing activities follow ISI procedures and regulations
- Support development and execution of process validation and verification test plans, protocols, and reports
- Maintain site level process FMEA and risk management files and update as required
- Support production ramp and work cross functionally on issue and support continuous improvement projects
- Support investigation and disposition of non-conformances, both internal and supplier related
- Product development: Support various product and subsystem type design changes (not a full design quality support) Participate in risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans
- Ensure design changes are established and implemented according to ISI standards and applicable regulations
- Recommend design processes and methods to meet quality goals (DFX, etc.)
- Quality Advocacy: Develop and apply corporate-level quality metrics
- Ensure the quality system requirements are effectively established and maintained
- Lead and manage quality initiatives in one or more areas of product and processes quality
- Evaluates deviations and non-conformances and supports resolution of quality issues Supports process validation and verification
- Perform risk analysis and determines quality disposition for variance requests and non- conformances
- Represents the department cross-functionally in meetings that may include senior and external personnel
- Releases process and document changes through engineering change orders and deviations using ISI change control process
- Escalates to direct management all quality issues that could impact patient safety or surgical efficacy
- Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk
- Performs other duties as assigned by management
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