alison acly , pmp
Project Management Consultant at Independent
project management consultant
material engineer 16 year experience innovative dynamic medical device company . current focus project management product development . project manager , lead cross-functional project team manage product development , commercial launch , on-going product support activity . specialty : project management , design control , product development ( concept initiation commercial release ) , preclinical device development ( animal study / ex-vivo study / bench testing ) , nitinol device , solidworks , salesforce , siebel crm , sap .
Independent
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.
Santa Clara, Ca
Project Management Consultant
Grifols
https://www.linkedin.com/company/grifols
Manages the business technical support and change management for Grifols Diagnostic Solutions. Partners with the IT organization to maintain and improve the usability of the application. Provides service and support globally.

-	Designee for GDS Siebel System Owner
-	GST business expert on the interaction interface of Siebel, SAP and hardware support
-	Develop and assists business to deliver end-user training to new employees/groups
-	Participates in various projects or product teams to provide product or organization insight
-       Build and deliver performance reports based on Siebel CRM (Oracle Business Intelligence        Enterprise Edition) and ERP (SAP) business intelligence to allow data-driven decision making
-       Articulate complex ideas with easy-to-understand charts and tables:Pivot table/chart   
        manipulation within Excel 
-       Assists in maintaining master data integrity in SAP
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Business System Analyst with Siebel and SAP – Global Service and Training (GS&T)
Infiniti Orthopedics
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.
Product Development Manager
SI-BONE, Inc.
https://www.linkedin.com/company/si-bone
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.
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Engineer Project Manager
SpineAlign Medical, Inc
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.
Project Manager
Nitinol Devices & Components, Inc.
https://www.linkedin.com/company/confluent-medical-technologies
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.
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R&D Development Engineer II
Nitinol Devices & Components, Inc.
https://www.linkedin.com/company/confluent-medical-technologies
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.
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Quality Engineer II (Medical Side)
Nitinol Devices & Components, Inc.
https://www.linkedin.com/company/confluent-medical-technologies
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.
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Quality Engineer I (Trade Side)
BS
Materials Engineering
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California Polytechnic State University-San Luis Obispo
https://www.linkedin.com/school/california-polytechnic-state-university-san-luis-o/
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PMP
https://www.linkedin.com/in/tom-brigaitis-a6495a21
Woonsocket, RI
Tom Brigaitis
Quality Engineering Manager at Medrobotics Corporation
https://in.linkedin.com/in/sanjanasarma
Chennai
Sanjana Sarma
Regional Talent Partner - APAC at Vestas
https://www.linkedin.com/in/r-williams-b96aaa1a
Indianapolis, IN
R. williams
supervisor/stage hand at American Stage Company
https://www.linkedin.com/in/steven-fford-2487a3155
Ceres, CA
Steven fFord
Level 9 Mechanic at E 7 J Gallo Winery
https://www.linkedin.com/in/alejandro-sanchez-924811197
Modesto-Merced Area
Alejandro Sanchez
cellar operator at Bronco Wine Company
https://www.linkedin.com/in/emmanuel-rodriguez-b70b76159
San Jose, CA
Emmanuel rodriguez
Industrial Technician at The Wine Group
https://www.linkedin.com/in/gilbert-blocker-bbb92588
St Louis, MO
gilbert blocker
engineer at Union Pacific Railroad
https://www.linkedin.com/in/paul-gross-519a1743
Riverbank, CA
Paul Gross
Skilled Materials Handler at E& J Gallo
https://www.linkedin.com/in/arsenio-amigable-12b55b180
Stockton, CA
Arsenio Amigable
Warehouse Operator II at The Wine Group
https://cn.linkedin.com/in/chen-xidong-tony-3b21b581
Shanghai, China
Chen Xidong/Tony
Senior mechanical engineer at Philips Healthcare
https://www.linkedin.com/in/rene-ramirez-14112882
United States
Rene Ramirez
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https://www.linkedin.com/in/ruben-lee-garza-ab446119b
Salinas, CA
Ruben Lee Garza
Wine cellar worker at The Wine Group
https://www.linkedin.com/in/steven-yeats-37b0b0172
Stockton, CA
Steven Yeats
Heavy Equipment Operator at The Wine Group
https://www.linkedin.com/in/laura-fletes-74b505192
Modesto-Merced Area
Laura Fletes
cajera en hacienda San Sebastian
https://www.linkedin.com/in/scolly-sandoval-68b5591a3
Modesto, CA
Scolly Sandoval
trabajadora de campo en vineyards winery
https://www.linkedin.com/in/dennis-travis-94b1b914
Modesto, CA
Dennis Travis
Independent Computer & Network Security Professional
https://www.linkedin.com/in/roberto-regalado-40b2681bb
Ceres, CA
roberto regalado
Security Officer at Bronco Wine Company
https://www.linkedin.com/in/enrique-gomez-96ab00174
Greater Monroe Area
Enrique Gomez
General Winery Worker at The Wine Group
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Announcing Dolby Dimension. I am super proud to have been part of the amazing team that brought these to market!…
California Polytechnic State University San Luis Obispo Alumni
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https://www.linkedin.com/groups/80105
Medical Device Opportunity
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https://www.linkedin.com/groups/131648
Cal Poly, San Luis Obispo - College of Engineering Alumni
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https://www.linkedin.com/groups/2139914
Medical Device Engineers Network
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https://www.linkedin.com/groups/85363
Medical Device Networkers -Now Active on FaceBook!
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https://www.linkedin.com/groups/3308