Overview
Quality Engineer/CPK/GR&R/Reliability Jobs in Sunnyvale, California, USA at Intuitive
Position: Quality Engineer 2 (CPK/GR&R/Reliability)
Job Description
Primary Function of Position:
Intuitive seeks an effective technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, drive projects to implement these initiatives, and serve as a professional consultant to help solve the most technically challenging quality problems. The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics, and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization.
You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality. And you will be also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.
Roles & Responsibilities:
Quality Advocacy and Project Management
Develop and apply corporate level quality metrics.
Drive and project manage quality initiatives in one or more of these focus areas:
Product Quality
Data Quality
Process Quality
New Product Development and Sustaining/Manufacturing Support
Handle projects of various product and subsystem types (electrical, mechanical, optical, etc).
Develop measurable goals for quality.
Ensuring that the essential performance aspects are mitigated in the product quality plans.
Identify critical elements of designs. Recommend design processes and methods to meet quality goals: DFX, etc.
Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
Plan and creation quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for incoming materials and finished devices.
Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
Analyze and disposition of discrepant materials.
Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments.
Support development and execution of process validation and verification test plans, protocols, and reports.
Support development and execution of manufacturing line qualification plans, protocols, and reports.
Failure Analysis
Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
Perform technical failure analysis based on the physics of failure.
Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
Any other Quality Engineering related function/responsibility as directed by the manager.
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Title: Quality Engineer/CPK/GR&R/Reliability
Company: Intuitive
Location: Sunnyvale, California, USA
Category: Engineering (Quality Engineering), Quality Assurance – QA/QC (Quality Engineering)
