Job Description
Primary Function of Position:
Intuitive seeks a strong technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert 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 optics, 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 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 and Responsibilities:
This position has responsibility and authority for:
- New Product Development and Sustaining/Manufacturing Support
- Handle projects of various product and subsystem/component types (electrical, mechanical, optical, etc).
- Develop measurable goals for quality.
- Lead Quality Table meetings.
- Ensuring that the essential performance aspects are mitigated in the product quality plans.
- Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
- Plan and create quality standards, quality control, and quality assurance procedures, 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 material.
- 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. Support and drive SMVP/R projects.
- Failure Analysis
- Provide quality expertise to the quality engineering support team to analyze the product failure.
- Perform deep 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.
- Quality Advocacy and Project Management
- Create, process and review various types of Quality Notifications and Change Orders.
- Apply corporate level quality metrics. Lead quality meetings e.g. QDR (Quality Data Review).
- Lead and project manage quality initiatives in one or more of these focus areas: Product Quality, Data Quality and Process Quality.
- Perform mock audits and Gemba walks to ensure compliance with ISI QMS.
- Any other Quality Engineering related function/responsibility as directed by the manager.
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