Materials Engineer with 12 years of experience in innovative and dynamic medical device companies. My current focus is Project Management and Product Development. As a Project Manager, I lead cross-functional project teams to manage product development, commercial launches, and on-going product support activities. Specialties: Project Management, Design Control, Product Development (Concept Initiation through Commercial Release), Preclinical Device Development (Animal Studies / Ex-Vivo Studies / Bench Testing), Nitinol Devices, SolidWorks.

Project Management Consultant @ Develop and maintain project timelines. Support Program/Project Planning. Manage design and development process. Coordinate vendors and project operations. Develop, maintain, and repair design control systems and documentation. Pre-clinical Medical Device Development. Support R&D, Clinical, Quality and Regulatory as needed. From March 2013 to Present (2 years 10 months) Product Development Manager @ Coordinated multiple vendors to meet product development timelines. Developed and executed product test plans and documented test results. Authored technical specs for spinal fixation components and compliant spinal screws. Assisted with progress reports for executive level management on status of all projects. Responsible for creating and maintaining project timelines. Participated at strategic level for all projects – Direction, activities and communication. Assisted drafting of implementation plan for QMS. Organized and interpreted legacy project data to identify detrimental design flaw in previously successful device design. From November 2012 to March 2013 (5 months) Engineer Project Manager @ Trained, mentored and led personnel within a technical team environment. Managed and led a newly designed Mallet and second generation instruments to commercial release. Led development team, ensuring design specifications were achieved and timelines met through weekly meetings and design reviews. Applied expertise in FDA compliant medical device design control to implement newly designed quality system on project iterations. Analyzed surgical tool performance and developed surgical techniques using simulated test setups and cadaver based labs. Coordinated in parallel project activities, timelines, and external manufacturing for multiple class III and class I projects. From May 2011 to November 2012 (1 year 7 months) Project Manager @ Applied Nitinol expertise to implement new designs to improve device function. Managed and coordinated all aspects of the VerteLift System project through four generations; starting with prototyping and culminating in commercial release in the EU. Utilized Design Control knowledge to compile and maintained multiple DHF’s for various product lines. Led design reviews, managed vendors, trained colleagues on system, designed bench top testing, wrote verification protocols, product specifications, and manufacturing instructions. Successfully compiled Essential Requirements checklists, FMEA’s, and Hazard Analyses. Coordinated FDA testing with outside laboratories. Conducted cadaver studies to evaluate and document device performance. Assisted with post-market surveillance cases in Europe. Filed six patent applications for various company product lines. From November 2007 to April 2011 (3 years 6 months) R&D Development Engineer II @ Developed a validation strategy for the manufacturing process. Designed custom tooling to support various customer components. Performed failure analysis on customer components. Coordinated with customers, sales, and engineers to create manufacturing process per customer specs. Developed process for prototyping components that allowed the device to be compressed down to a microcatheter inner diameter between .018” and .021”. Designed and performed testing on a flow model to assess the functional characteristics of prototypes in a neurovascular environment. Developed different types of blood clot models for simulation experiments. Developed program in Power Lab for data acquisition. Filed 1 provisional application for an Ischemic Stroke device. Conducted ex-vivo testing with animal organs. Responsible for prototyping aortic valves. Designed molds supporting Nitinol thin film feasibility study including gold and copper plating of mold. Organized, supervised, and delegated specific tasks to R&D technicians. Coordinated contract R&D vendors supporting Nitinol thin film processing. Conducted diligence activities on aortic valve competitive landscape. Researched and conceived alternative ways to percutaneously access aortic valve. Attended conferences and interacted with physicians. From May 2005 to October 2007 (2 years 6 months) Quality Engineer II (Medical Side) @ Developed and implemented production process audit checklists. Assisted with quality system audits performed on the company and suppliers. Developed inspection plans for incoming components from vendors, in process, and final QC inspections. Performed, assisted and advised on equipment validations and test method validations. From January 2004 to May 2005 (1 year 5 months) Quality Engineer I (Trade Side) @ Performed daily tasks of specification/contract reviews, NCR’s, customer complaints, and CAPA’s. Designed and implemented methods for testing and evaluating the accuracy of inspection equipment. Organized, Supervised, and delegated specific tasks to Quality Control personnel. From September 2002 to January 2004 (1 year 5 months)

BS, Materials Engineering @ California Polytechnic State University-San Luis Obispo From 1997 to 2002 Alison (Souza) Acly, PMP is skilled in: Design Control, Medical Devices, FDA, R&D, Quality System, Validation, V&V, Manufacturing, Testing, ISO 13485, Biomedical Engineering, Design of Experiments, CAPA, Solidworks, Quality Control