Operations Executive Operations / Engineering Medical Devices

AMAURY GONZALEZ

**** ******* ******, ****** ** **326 (C) 954-***-****

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OPERATIONS EXECUTIVE OPERATIONS / ENGINEERING MEDICAL DEVICES

Operations executive with 17+ years of experience in the Medical Device industry with 12 years in leadership roles of

increased strategic value. Recognized as results oriented, adaptable and empowering leader who develops high-performing,

self-driven teams with exceptional accountability. Transforms organizations through strategic planning, talent selection

and development, and a practical business improvement expertise. Proven leadership in turn-around and start-up business

scenarios. Expertise includes:

Operations/Business Management – Strategic Planning and Execution – Product and Process Development

– Quality Systems Improvement – Change Management – Lean-Six Sigma Expertise – Environmental,

Health and Safety – Project Management – Technology Transfer – Leadership Development

PROFESSIONAL EXPERIENCE

AMERICAN MEDICAL SYSTEMS (ENDO SOLUTIONS)2012 - 2013

$2.8 billion global provider of end-to-end solutions for care pathways in the pain and urology markets

Senior Director, Operations and Global Distribution, Minnetonka, MN (2012 – 2013)

Reporting to the Sr. Vice President of Operations and Supply Chain, lead operations and engineering functions,

including production, distribution, logistics, manufacturing engineering, industrial engineering, product builders

training and facilities. Manage operating budget of $50 million, volume of 40 thousand finish device shipments

through 8 manufacturing/distribution facilities in global network.

Drive the creation of Operating Management System (OMS) and development of Global Operations and

Supply Chain Playbook

o Development of department strategic imperatives, management foundations, metric dashboards

and operating mechanisms

o Personally trained global network managers on identified OMS best practices and Playbook

o Work used as “best-in-class” example at meeting with Endo’s Chairman of the Board of Directors

Developed global distribution strategy to significantly improve responsiveness and overall customer

experience.

o Development and standardization of quality controls, attaining 80% reduction of customer

complaints and escape events

o Network optimization resulting in 40% cost reduction in domestic market

o Reduction of transit inventory by 30%, resulting in cycle time reduction of 4 days

Executive Sponsor for network Continuous Improvement strategy

o 10% YoY COGS reduction

o Development of industrial engineering team, engineering skills matrix and toolkit

o Deployment of Process Excellence program

BOSTON SCIENTIFIC / GUIDANT CORPORATION1996 - 2012

$8 billion global manufacturer of cardiac, endosurgery, peripheral and pain management solutions

Senior Director, Operations and Manufacturing Engineering, Miami, FL (2008 – Present)

Reporting to the Vice President of Operations, lead a 24/7 operations and engineering functions, including

production, manufacturing engineering, industrial engineering, product builders training, preventive maintenance,

EH&S, security and facilities. Manage operating budget of $150 million, volume of 4.5 million finish device

shipments and over 1000 direct and indirect reports. Center of excellence for precision machining, injection molding

and coating processes.

Executed aggressive business turn around in the areas of quality, service and cost for the second largest

plant in the network.

Reduced field actions from five to zero and major audit findings from 15 to zero

AMAURY GONZALEZ

Decreased number of outstanding CAPAs by two-thirds, trimmed scrap by over 50%, and

reduced line clearance issues by >70%

Realized $10 million an annual cost savings

Improved customer service line file rate from 97% to over 99.7%, and reduced the customer

back orders from over $2M to under $30k

Led cross-functional effort for attainment of ISO 14001 certification. Implemented and actively managed

Environmental Management System (EMS)

Create and drive timely execution of operational plans for transfer of products to CR and site

decommissioning ($40M value improvement project)

Director, Process Development, St Paul, MN (2007-2008)

Directed global highly technical organization, including development engineers, technicians, model shop and

metrology laboratory; responsible for the process development for the cardiac pacemaker and defibrillation leads

franchise and $2.7M functional budget. Provided leadership to 130 employees in Minnesota, Puerto Rico and

Germany.

• Created business case for the investment in leads manufacturing technology, increasing annual funds

of $3M to $10M; revolutionized process platform, removed future development constraints and delivered

8% increase in gross margins

• Spear-headed vertical integration effort to integrate key design/process assemblies increasing

flexibility and resulting in $30M material savings

• Developed global automation and equipment maintenance network that supported technology growth

without increased overhead

• Sought out by Executive Committee to lead at-risk strategic development project; delivered

commercially viable product, 240% yield improvement and 550% increase in productivity in record time

• Presented proposals and updates on key leads franchise projects to Product Investment Board and

Business Planning Team

• Led Diversity Inclusion Group HOLA (Hispanic Organization for Leadership Advancement) as

Executive Sponsor to close gap between organizational construct and customer demographics

Manager, Material Replacement, St Paul, MN (2005-2007)

Created new team of 12 R&D engineers and 2 project coordinators tasked with the proactive identification,

development, testing and commercialization of replacement materials to guarantee business continuity. Indirect staff

of 5 process development engineers located at manufacturing site in Puerto Rico. Managed annual expense budget

of $6.5M.

• Led standardization of Project Management principles resulting in disciplined delivery of projects

constantly on-time/on-schedule; became benchmark for other development teams.

• Managed adhesives, polymer extrusions, coatings, and pharmaceuticals; complied with Medical

Device CDRH and Drug Combination Device CDER requirements.

• Led company-wide quality system overhaul project as Process Steering Committee Lead; achieved

successful clearance of regulatory constraints imposed on the company

Technology Transfer Manager, Dorado, PR (2003-2005)

Led all product transfer projects from Cardiac Rhythm Management (MN), Cardiac Surgery (CA) and Vascular

Intervention (CA) business units to Puerto Rico plant. Staff of 14 process development engineers and 2 supervisors;

indirect staff of 40 product builders and 10 equipment/process technicians. Managed $7M expense budget and $3M

capital investment

Delivered on all 12 new product development projects and 6 existing product platform inch-up projects

on-time/on-budget

Created business case for implementation of Design for Manufacturability (DFM) concepts,

significantly increasing strategic value of site in product development cycle

Increased averaged of new product introduction yield by 50%

Reduced site effective tax rate to less than 2%; positioned site to take advantage of “Pioneering

Product” tax exemption law and developed partnership with local suppliers

AMAURY GONZALEZ

Manager, Manufacturing, Dorado, PR (2002-2003)

Responsible of three lead assembly platforms with annual value of production of $82M. Staff of 7 Production

Supervisors and 4 Manufacturing Engineers.

Championed Six Sigma strategy within the World Class Steering Committee and oversaw Lean

Learning Laboratory. Delivered $4M in improvement savings the first year. Improvements were highlighted in

Industry Week’s Best Plants Award.

Received Corporate President’s Award for record-setting ramp and launch of strategically critical

product platform

Group Leader, Process Development, Dorado, PR (2001-2002)

Led continued development of new manufacturing technologies: liquid injection molding, iridium oxide coating,

micro laser welding, vision systems, testing equipment automation, epoxy and silicone-based adhesives

Delivered $2M in productivity improvement projects through development of automation solutions

Increased site strategic value through the expansion of manufacturing core competencies and recruitment of

key technical talent

Engineer, Project/Quality II, Dorado, PR (1996-2001)

Re-engineered key quality systems and provided leadership for transfer of new products acquired through the

strategic purchase of major competitor

Received Corporate President’s Award for outstanding contributions and execution of 2 key product

transfers in a very aggressive timeline of 9 months

Led design and validation of parametric release ethylene-oxide sterilization process (first across the

network); reduced overall product release cycle time by 80%

Received site Excellence’s Award for outstanding contributions and execution of site-critical quality system

improvement projects (Part 11 compliance automated traceability system, electronic training management

system, statistical process control program)

Led process remediation effort resulting in clearance of critical regulatory non-conformance and sub-

sequent audit with zero findings

EDUCATION / OTHER

Bachelor of Science in Mechanical Engineering – University of Puerto Rico – Mayaguez, PR (5-year engineering

program)

Specialized/Applicable Trainings

Finance for the Nonfinancial Manager – Leading Through Change – Maximizing Performance – Lean Experience –

Execution for Results – People First Leadership Development Program – Lean-Six Sigma Champion Training/Six-

Sigma Green Belt Training – Project Management Professional Training (PMBOK)

Languages: English/Spanish business proficiency

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