Kara Boucher Email & Phone Number

Atlanta, Ga, Us

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Kennesaw, Georgia, United States

• Lead process improvement projects to improve safety, process efficiency, cost savings, and environmental impact.• Manage continuity and second-source projects for 2 product lines to prevent line down revenue loss situations by identifying, sourcing, qualifying, and implementing alternative materials or in-house procedures.• Support EUMDR activities by creating MDR-compliant product and component drawings and providing process engineering insight on product lines.• Modeled fixtures and tools in SolidWorks to align with current practices and improve process efficiency, operator confidence, and safety•Mentored new hires on change control procedures, engineering studies, test methods, and good manufacturing practices

Atlanta, Georgia, United States

• Lead design transfer activities to transfer 4 products from new product development to manufacturing.• Created quality system using FDA guidance documents to implement a custom implant ordering process.• Manage Sustaining Engineering projects for 5 product lines to innovate current offerings.• Develop and execute process qualifications and validations, operation qualifications, and installation qualification protocols and reports in order to transfer 4 products to manufacturing.• Model assembly fixtures in SolidWorks to improve operator ergonomics and efficiency to accompany finished goods inventory growth.• Generate process specifications and record forms for the manufacturing of new product lines.

Atlanta, Ga

• Updated implant assembly and packaging process specifications and incoming inspection plans of raw goods to increase amount of conforming product, and improve operator comprehension of work instructions.• Generated product and process waivers and non-conformance reports.• Developed and implemented hard gaging inspection aid to reduce inspection time and improve accuracy and ease of inspection.

Atlanta, Ga

• Conducted FDA testing for a new implants• Modeled and prototyped implants for Instron testing using SolidWorks and CNC machines• Wrote literature reviews on medical devices and shape memory polymers

• Call alumni for the Roll Call program• Generated over $50,000 in pledges last fiscal year• Winner of three incentive based challenges, including attending the President’s Dinner• Earned a certificate for getting over 1,000 pledges to the program