Anthony C. Aliberto

Aliso Viejo, CA *****

949-***-**** adxxfx@r.postjobfree.com

URL: www.linkedin.com/in/Meddeviceprofessional

Multi-discipline specialist in all features of medical device design from concept to final release. Product deliverables include Balloon, PICC and CVC Catheters, Vascular Grafts, Drug and Neurovascular and Cardiovascular Stent Delivery Systems, Infusion Pumps and Infusion Sets, RF and Cryoablation Electrophysiology catheters and Defibrillator Leads Design. Mentoring and training expertise with colleagues for the overall success of several high risk projects. Savvy Engineering Leader with an creative reputation for delivering conceptual design strategies meeting the Quality Systems and Regulatory directives for Class I/II/III 510k and PMA devices.

Mechanical engineering knowledge of state-of-the-art tooling and equipment meeting design specifications for diagnostic and therapeutic applications with broad experience designing prototype Vascular Grafts, Stent and Drug Delivery, Electrophysiology catheters and sheaths.

Hands-on plastic parts design utilizing engineering grade resins, injection molding and mold design, extrusion of single and multiple lumen tubing, processing equipment design.

Customize complex design for manufacturability, and processing for implantable bypass grafts, high-volume disposable medical devices and customer driven commodity items.

Proactive with bringing Design History Files to quality standards.

Acquired extensive experience with FDA design control requirements, FMEA, risk analysis, finite element analysis, 3-D modeling and design, MiniTab, and fluid dynamics.

Engaged and updated on materials and process flow for manufacturing - subject matter expert.

Create protocols, test reports identifying potential risks and analysis for mitigating risks.

Supplier Quality Assurance auditor assuring compliance to the MQM standard. INTEGRATED DESIGN ENGINEERING, Laguna Hills,CA

August 2017: Consultant

Principal

Consultant for start-up medical device company. Manage and organize the R&D Engineering adherence to the Quality Systems functional entity with emphasis on design, document systems guidelines, development and monitoring the effectiveness of the Risk Management system. BECTON-DICKINSON, Yorba Linda and Brea, CA

March 2017- August 2018: Contract ended.

Sr. Process R&D Engineering Contractor

Point person focused on program support in the analysis and testing of infusion system addressing product line improvements and line transfer facilitation. Preparation of documents for efficient project experiment with emphasis on design performance reliability and repeatability. OSCOR, Inc., Palm Harbor, FL

Oct 2016-Dec. 2016: Company restructured.

Director, Engineering

Staged remediation activities for improving the systematic approaches for existing and new product introductions from design risks to mitigation analysis for several catheter product lines. Updated as needed documentations meeting product requirement flow. Restructuring eliminated my position among several others in December, 2016.

RESEARCH AND DEVELOPMENT AND PROCESS ENGINEERING PROFESSIONAL PROFESSIONAL EXPERIENCE

Anthony C. Aliberto

ONSET MEDICAL, DIVISION OF TERUMO, Irvine, California Jun 2013- August 2016: Moved division to Maryland and closed the facility in Irvine, CA. Senior Process Development Engineer

Concentrated on new product designs for cardiovascular and urethral access sheath delivery markets.

Composed protocols and reports for IQ, OQ and PQ for new equipment to completion. Lined up process validation and remediation of Class II and Class III devices

Proactively provided ongoing technical support to Operations to insure smooth design transfer from R&D to manufacturing. Completed documentation for DHF closure.

Established production line process improvements, training, and transfer of product designs to remote division of Terumo.

COVIDIEN, EV3 DIVISION, Irvine, California

Mar 2011- Jun 2013: After being purchased, restructuring eliminated several positions. Senior Process Development Engineer

Managed development efforts of neurovascular project scope and timelines.

Created parallel comparison of materials, fabrication methods and processing equipment to verify and reproduce controlled outcomes of product design specifications.

Evaluated the tradeoffs between internal and external design developments, making decisions that were most advantageous for the product and the company.

Sustained engineering with custom designed stents for neurovascular applications. ST. JUDE MEDICAL, INC, Irvine California

Apr 2006- May 2010: Company restructured and position eliminated along with several others. Research and Development Manager, Atrial Fibrillation Division

Directed staff of 17 with $2,300,000 budget for strategic product design, new technology development for multiple product lines, supplier management, prototyping, design verification testing, production transfer of diagnostic and therapeutic electrophysiology catheter products.

Initiated and sustained network of support through key collaborative approaches, and proactively served in development plans and training for engineering staff in areas of GMP, statistical analysis, and lean/six sigma tools.

Coached, educated and worked closely with cross-functional departments to achieve goals.

Launched various improved and new special order diagnostic and therapeutic Electrophysiology products for Asian markets, increasing total revenues from $27,000,000 to $38,000,000 over two- year time period.

Collaborated with key opinion leading physicians to implement development strategy for new product designs in Asian markets, meeting customer requirements and reducing overhead, material, and distribution costs by 30%.

Utilized resource planning using organizational, technical, and interpersonal interfaces based upon needs analysis of specific projects. Reviewed and updated Design History Files to Quality and Regulatory standards.

Supported high-risk EP projects by coordinating and integrating necessary design elements into each project life cycle. Maintained constant communication with cross-functional departments and senior management for department updates and transactional analysis of project and team directions. Delivered quarterly presentations to division president and inter-departmental leaders with status and proposed forward thinking strategy promoting business case. Anthony C. Aliberto

STEREOTAXIS, Maple Grove, Minnesota

March 2003 – July 2005: Project was completed and there was no more work available. Principal Engineer

Engineering focused scientist with assigned management of staff of four researchers and an

$870K budget for all aspects of design and development of novel micro-catheter, guide catheter, and electrophysiology catheters utilizing a revolutionary magnetic navigation system.

Global commercialization and contributed to positively impacting company revenue growth. BOSTON SCIENTIFIC, San Jose, California

Principal Engineer

2001-2003: Position eliminated due to product line completion.

Served as project team leader on multi-functional team driving design and project management for development of specialized balloon for administering radiofrequency ablation. Designed and validated particular materials for fabricating balloon and delivering proof-of-concept creating complete ring of fire on site-specific cardiovascular anatomical model. Managed product studies of ablation catheters to measure degree of gaps during application of long linear lesions. Proposed successful solution to close procedural gaps in clinical setting by demonstrating process control. Monitored injection molding of integral components with choice materials and design. Additional Experience (Permanent and Consulting):

Meadox Medical, Oakland, NJ, Project Leader in the design and fabrication of single lumen and bifurcated implantable vascular grafts for cardiovascular applications

Ventritex, Sunnyvale, CA, Manufacturing Engineer on Electrical Leads for Defibrillators

EV3, Division of Covidien, Irvine, California, Performed process validation for new product design

Syprosoft Engineering, Irvine, California, Consulting on various customer request products

Microtherapeutics (Neurovascular R&D), Irvine, CA, Lead effort in stent delivery system

Sterilis (Gyntlecare), Fountain Valley, CA, Design and fabrication of gynecology products

Schneider, Maple Grove, MN., Design of angioplasty delivery systems

BIT, Irvine, CA, Performed Design Failure Mode Effects Analysis for Immunoassay IVD equipment.

GLOBAL BIOMEDICAL and INTEGRATED DESIGN ENGINEERING CONSULTANCY, Orange County, California

2000 – Present

Engineering consultant for the Medical Devices Industry.

Performed multiple design and development projects for both startup ventures and established medical device companies.

Note: The consultancy periods occurred intermittently between full time permanent positions EDUCATION:

Long Island University, Brooklyn, New York M.S., Pharmaceutical Administration College of New Rochelle, New Rochelle, New York B.S., Chemistry INTERESTS:

Playwright, reading, trail hiking, bicycling, sailing, mechanical aptitude, volunteering with deaf and hearing impaired groups.

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