Quality Engineer 3
2 weeks 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 and remanufacturing of systems for the Davinci Multiport business unit.
Roles & Responsibilities:
- Initial roles and responsibilities for this position will include the following:
- 40% involvement in supporting sustaining manufacturing operations, 25% improving supplier processes, 20% 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.
Supplier Processed improvement:
- Working closely with ISI supplier engineering group to enhance the quality of the product and improve the supplier process.
- Investigate, Analyze the supplier non-conformances (VR) and work with Supplier engineering group and Suppliers to prevent recurrences and improve the processes.
- Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive's requirements for supplier excellence using a collection of best practices in project management, Six Sigma, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.
- Support part qualification deliverables include: Process FMEA, Process Capability Analysis, FAIR, Process Validations, Inspection Reports, and Gage R&R.
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.
- Drive 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 establishes 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 the management.
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