Caitlin - engineer

Full CV / Resume

SUMMARY:

Customer focused Quality Engineer experienced with Corrective and Preventive Actions (CAPA), production line quality and trained in review and approval of final device history records. Accustomed to handling compliance and quality support for ISO13485, ISO9001, and 21 CFR 820 products. Accomplished in Quality System Regulation implementation and improvement activities, customer complaints, process validation, and process improvements.

WORK EXPERIENCE:

May 2015 - Associate Quality Engineer Worcester, MA
Present Cogmedix
• Supported the sustainment of existing products through 492 Non Conformance investigations
• Lead by example to promote the criticality of strict ISO13485, ISO9001 and 21 CFR 820 compliance adherence
• Conducted training of personnel, including customers and suppliers on workmanship and quality standards
• Supported process design and validation for New Product Introduction (NPI)
• Reviewed device history records for quality approval as needed
• Participated in the company’s Lean and Continuous Improvement programs
• Initiated 6 supplier Corrective Actions and drove them to closure
• Implemented methods and procedures for inspecting the precision and accuracy of finished products
• Produced analysis that is accurate, timely and actionable and presented Weekly Data Metrics to our customer


October 2013 - Healthcare Sales Representative Lake Forest, IL
March 2015 Hospira
Responsible for the promotion of Devices and Pharmaceuticals into hospitals throughout the United States
• Consistently engaged, influenced and supported customers throughout the selling process
• Executed all duties and responsibilities in accordance with all company policies, practices and procedures

Device and Technology Systems:
• Managed the New England Territory of 548 s
• Certified in Device Training, S&C Training, and Miller Heiman Conceptual/Strategic Selling
• Utilized field travel and EX to gain 5 year, Multimillion dollar hospital contracts for Infusion
Devices and consumables
• Provided effective crisis control to 548 hospitals during the IV Solution shortage through efficient communication, comprehensive knowledge, and proficient problem solving

Specialty Injectable Pharmaceuticals
• Promoted growth in the USA South East hospitals
• Grew market share of Hospira injectable pharmaceuticals by utilizing competitors’ shortfalls
• Recaptured lost business by communicating Hospira supply recovery to Directors of Pharmacy, promoting a Partnership relationship
• Converted hospitals to using Hospira value–add products through facilitation of advanced clinical discussions
• Gained in-depth competitive market knowledge of Catheter Patency Devices, Infection Control Devices, and Closed System Transfer Devices for Oncolytics/Hazardous Drugs


PROJECT EXPERIENCE:

August 2012 - Thoracentesis Surgical Simulator Worcester, MA
May 2013 Worcester Polytechnic Institute
• Managed a 3 person team to design a versatile, anatomically accurate human thoracic cavity model, which can be used for emergency surgical training
• Collaborated with surgeons and conducted background research to fabricate prototypes of the surgical simulator



August 2012 - WPI Micro Patch Worcester, MA
Dec 2012 Worcester Polytechnic Institute
• Conducted background research on the limitations associated with clinically available Microelectrode Arrays (MEA) for neural stimulation
• Determined the engineering criteria and produced design alternatives for a soft, flexible MEA that will conform to the surface of the brain and provide stimulation via non-penetrating surface electrodes
August 2011 - Based Snow-Sport Injury Reduction Study Worcester, MA
May 2012 Worcester Polytechnic Institute
• Employed unique marketing strategies to promote our site (Designed the graphic arts components: flyers, banners, site images)
• Provided HTML coding for the site

Skills:

Software Microsoft Office, Sales Force, Basic Analytical Tool, Espirit MATLAB, Maple, HTML coding, LabVIEW, SolidWorks, Mathematica
Lab Small animal surgery, Analyzing EKG signals, Microscopy, Basic laboratory skills

EDUCATION:

October 2013 Worcester Polytechnic Institute (WPI) – Worcester, MA
in Biomedical Engineering, Concentration in Biomaterials & Tissue Engineering