Lisa Heller

Richmond Hts, OH *****

cell: 571-***-**** email: act9sh@r.postjobfree.com

SUMMARY OF QUALIFICATIONS AND SKILLS

Project Management experience (4 years), FDA compliance experience (7 years), Process/Design Improvement (7 years) Green Belt Certified, Lean Trained, Kepner Tregoe Trained, Toastmasters member, intensely analytical, focused on Manufacturability, Metal and Wood Shop experience, proficient in: Inventor, MATLAB, MathCAD, SolidWorks, Java, C/C++, Microsoft Office, Minitab

PROFESSIONAL EXPERIENCE

Philips Healthcare - Manufacturing Engineer, PET/CT Systems Highland Hts, OH July 2011-February 2016

● Led the redesign and restart of one of the CT build lines to ensure compliance with 21 CFR Part 820 o Led a practice build to update outdated procedures, optimize step execution, update product design for manufacturability

Produced 595 pages of work instructions and 105 pages of datasheets for system DHR o Redesigned the line flow to balance takt time for each work station o Updated work areas with new and streamlined tooling, adding workbench area, and ensuring ESD compliance o Completed PQ to validate crimping process on the line

● Instructor for 6 hour manufacturing process introduction (administered site wide in small sessions)

● Championed a cost reductions project for Shipment Missing on Arrivals with an estimated annual hard savings of $250k

● Served as Operations Representative on Core Cross functional Team for latest New Product Introduction o Team consisted of Reps from System Engineering, Customer Support, Quality/Regulatory o Was in charge of monitoring manufacturing metrics for team and management reviews o Supported the production of 3 pilot and 6 prototype units, generated the manufacturing procedures to be used in production, and executed the manufacturing PPQ, successfully transferring the product to production o Produced and sold 28 units of the Ingenuity TF PET/CT system

● Represented Operations as the PET Change Review Board member (reviews and assigns all Change Requests)

● Resolved defect reports to prevent delays in production and segregate and address defective material Medical Solutions, Inc – Project Engineer Chantilly, VA August 2009-June 2011 Worked on projects developing both sterile-disposable and durable goods. Highlights from two of the projects I managed: Custom Sterile Drape Product

Developed the product design based on project objectives endorsed by a multi-disciplinary team:

● Reviewed the design with vendors to improve functionality, material choice, and ease of fabrication.

● Created feasibility and verification testing protocols and tested all received samples. Created and maintained all documentation, including a design history file and test reports (FDA 21 CFR 820). Data Collection and Printing System

This product was developed to provide additional functionality to all of the company’s products by recording the solution temperature during testing and producing an electronic and paper record automatically.

● Performed verification testing on prototype hardware as software deliverables were provided by third party developer

● Worked with developer to troubleshoot and address software issues

● Determined that the hardware that had been sourced was missing a key component.

● Performed a vendor evaluation to select a new single board computer for the prototype. Case Western School of Engineering Cleveland, OH Fall 2008-Spring 2009 Senior Design Project, Group Leader - received an Honorable Mention commendation from Faculty. MetroHealth Hospital – Heart and Vascular Research Center Cleveland, OH June- Dec 2007 Cardiovascular Research Cooperative Internship

● Planned and executed electrophysiological experiments on cardiovascular sodium channels Case Western School of Engineering Cleveland, OH Spring 2007 Undergraduate Research Internship to design, optimize, and implement a urinary flowmeter for use in laboratory’s research EDUCATION

Case Western Reserve University, Cleveland, OH Graduated cum laude May 2009 Bachelor of Science in Biomedical Engineering, Bioelectric Sequence. Cumulative GPA: 3.6

● Dean’s Honor Roll or High Honors six out of seven semesters