Job Description

Essential Job Duties: Initial roles and responsibilities for this position will include the following:

50% involvement in supporting design and manufacturing projects, 15% failure investigation, 10% performing complex inspection, and 25% quality advocacy and project management.

1. Quality Advocacy and Project Management:
   • Develop and apply corporate level quality metrics.
   • Lead and project manage quality initiatives in one or more of these focus areas:
     • Product Quality
     • Data Quality
     • Process Quality
2. Production Facility Validation:
   • Planning, execution, and documentation.
     • MVP for building, product, and process located in Mexicali, B.C. Mexico.
3. Product Development:
   • Handle projects of various product and subsystem types (System, Instruments, Vision, new products, product improvements, etc).
   • Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at ISI Mexicali and OEM suppliers, utilizing clinical and engineering knowledge.
   • 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.
   • Develop and implement methods and procedures for disposition of discrepant material.
   • Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment.
4. Failure Analysis:
   • Provide quality expertise post-market release to the quality engineering support team to analyze the returned product.
   • 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.