Manuel Vélez Rodríguez

ADDRESS: Urb Camino de la Princesa 68 Guayama PR 00785

Calle Boina 77 Factor 1 Arecibo, PR 00612

Mobile: 787-***-**** E-Mail: acfjev@r.postjobfree.com

PRODUCT AND TECHNOLOGY TRANSFER AND PROJECT MANAGEMENT LEADER

Strategic and Technical leader and change agent with over 16 years of experience, global exposure and

outstanding record for driving large scale projects that grow business and organizational capacity for multinational

medical devices, aerospace, pharmaceutical and consulting companies with multibillion dollar revenues. Key

Business Partner with Expertise in:

NEW PRODUCT INTRODUCTION MANUFACTURING & LOGISTICS SUPPLIER VALIDATION

DESIGN VALIDATION & VERIFICATION CROSS-FUNCTIONAL COLLABORATION BUSINESS PROCESS RE-ENGINEERING

LEAN & SIX SIGMA DESIGN FOR MANUFACTURING (DFM) SOFTWARE DEVELOPMENT & VALIDATION

R&D AND NEW TECHNOLOGIES FDA & ISO REGULATIONS CAPACITY PLANNING & MFG TRANSFER

INJECTION MOLDING VALIDATION CONSENT DECREE REMEDIATION COMPONENT QUALIFICATION

KEY PERFORMANCE METRICS PROCESS & EQUIPMENT VALIDATION MANUFACTURING FLOOR RE-LAYOUT

FINANCIAL & BUDGET MANAGEMENT PROCESS DEVELOPMENT PEOPLE DEVELOPMENT

CORE COMPETENCIES:

Business Acumen / Accountability: Reach across different divisions and operational areas with extraordinary

influencing skills for sound business decision-making and plan development ensuring the continuity of new

products introduction pipeline is full. Accountable for complex divisional projects with multidisciplinary teams within

different locations with multi-million dollar budgets. Monitor and support key performance metrics such as yield,

scarp, product cost, cycle time, within others after product launch to ensure consistency from transfer values.

Manage special projects/changes that will support specific plant objectives.

People Development / Leadership: Promoted a performance and respect focused team culture; highly

recognized across the organization for encouraging and supporting others to express ideas and empowered

team members to take on to new challenges and make business decisions.

High-Value Service Delivery: Highly recognized for developing and establishing strong long-term strategic

partnerships with external (R&D, Sales and Marketing, Strategic Sourcing, RAQA, Suppliers) and internal

(Operations, Logistics, Packaging, Automation, Sterilization and Finance, etc.) clients working hand to hand to

develop optimum solutions based on needs by applying DFM and risk management techniques. Promote team

work oriented toward client needs, policies and procedures. Promote new technologies for higher efficiency and

state of the art operations. Intense focus to provide an outstanding Customer Experience throughout the entire

project. Managed mixed team which included Project Engineers, Advanced Manufacturing Engineers, Design

Engineers, Advanced Quality Engineers, Advanced Sourcing Leads and Engineering Technicians.

Mentorship Enrichment: Paired with a coach to improve leadership skills as well as serving as one to direct

reports to strengthen theirs. Managed performance evaluations for all direct reports as well provide feedback to

dotted line reports.

Enriched Communication: Anticipated needs, perspectives, and audience background to ensure transparent and

effective communication. Fluent in Spanish and English; knowledge of French.

CAREER MILESTONES/PERFORMANCE HIGHLIGHTS:

Commanded numerous highly complex projects, such as: New Products Introduction: (ReelX 4.5mm Knotless

Anchor, ICONiX All Suture Anchor, PEEK Twinloop Flex), Product Improvement: (Suture Color Change, Shaft

Breaking Prevention) Cost Improvements: (Change of suture processing from Spool to Strand ($264K cost

improvement, Energy Reduction Program (over $400K cost savings), CRM Implementations, Manufacturing

Capacity Planning and re-layout to support future growth, Acquisition Manufacturing Transfer, Documentation

Uncoupling, Consent Decree Remediation projects within many more with extraordinary results due to assertive

assessment, proper guidance, effective planning, control and execution.

Strengthen the business relationship with the Sport Medicine Division to ensure a strong product pipeline.

Increased the production output of the Sport Medicine Business Unit in more than 75% with the new products

introduced from 2011 to 2013.

Lead the Project Management Basics Academy for the New Products Introductions Team at Stryker PR in 2011

Won the Team of the Year Award in 2008

Launched the Mission Computer of the THAAD Missile to ensure the nation is properly protected

Founder and Former President of the Society of Hispanic Professional Engineers (SHPE) Student Chapter at

University of Puerto Rico, Mayaguez (1995-1997)

Thanks for Keeping the team focused and engaged to ensure we complete the product launch and being able to exceed the project goal –

Recognition Card from a Direct Report

PROFESSIONAL EXPERIENCE

Stryker Puerto Rico 2010 – Present

Advanced Operations Project Manager/Product &Technology Development Manager (2011 – Present)

Appointed as site lead to execute the new product introduction activities for the Sport Medicine Business which fulfill a

market of $1.2B with a team of four direct reports and eight indirect reports.

Business Alignment: Established a strong relationship with the Sport Medicine Division (R&D, Marketing,

RAQA Teams) to ensure strong new products pipeline was assigned to the Puerto Rico Plant. This team was

the only design transfer team in the corporation that has an R&D design engineer as a direct report.

Technology Management: Accountable for the implementation of the Set Based Thinking Tools Software which

enables the engineers to narrow down the design window of any process development they were assigned to.

Perform technical reviews for product design, process and fixtures development to ensure feasibility and proper

execution.

Project Management: Lead the successful product introduction of two major anchor platforms such as ICONIX ALL

Suture Anchor and REELX 4.5MM Knotless Anchor. Managed the entire validation and design transfer cycle which

includes activities such supplier selection and qualification, components qualification, process development and

characterization, fixtures development, capacity planning, line balancing, cleanroom re-layout, sterilization validation,

packaging validation, process validation, post market surveillance, project risk management, project resource

management, project time management, project cost management and project quality management.

Regulatory Compliance: Ensure all design control regulation requirements were met for each design transfer

project. Support Quality System Audits for both internal and external auditors. Ensure personnel are in compliance

with required trainings at all times.

Project Engineer – Stryker Puerto Rico (2010 – 2011)

Directed the Joint Preservation design transfer team to ensure on time and on budget project completions.

Project Management: Lead the successful product completion of two improvement projects (Suture Color Change

from white to green to allow surgeons to improve suture visibility during surgery and Titanium Intraline Shaft

Redesign to prevent shaft from breaking. Lead the introduction of the Peek Twinloop Flex Anchor new product

introduction. Lead the cost improvement change of suture processing from spool to individual strands generating a

saving of $264K.

Regulatory Compliance: Ensure all design control regulation requirements were met for each design transfer

project. Support Quality System Audits for both internal and external auditors. Ensure personnel are in compliance

with required trainings at all times.

Honeywell Aerospace Aguadilla, PR 2008 – 2010

Project Engineer, 2009 - 2010

Led and Support all Program related activities such as Customer Interface, Deliverable and Milestones

Management, Subcontract Management, Proposal, Risk, Cost, Schedule, Scope and Quality throughout the

entire Project Life Cycle for the $100MM Space Based InfraRed System (SBIRS) Program.

Project Management: Ensured the $23MM budget was appropriately managed as well as ensuring all project

activities were executed on time.

Training and Mentoring: served as a mentor to the Engineering Project Office team members.

Risk Management: Established priorities with the Lockheed Martin Team to ensure any project risks were

managed and mitigated.

Cost Improvement: Achieve program incentive of $102K by delivering on time the Manufacturing Readiness

Review package to the customer. Led the Energy Reduction Team achieving a saving of $400K in energy

consumption thru multiple energy saving initiatives.

Program Planning and Control Analyst, 2008 - 2009

Integrated the Master Schedule to tie-out all related systems for proper project monitoring and execution of

the Terminal High Altitude Area Defense Missile (THAAD) Inertia Measurement Unit and Mission Computer

production deliverables as well as create special recovery schedules to overcome risk of late delivery.

Project Management: Support the Management Reserve recovery process by increasing the reserve in an extra

$250K(CPFF) for s new total of $1.9MM

Technology Management: Create a dashboard tool to improve program management visibility on production

Manuel Vélez Rodríguez

ADDRESS: Urb Camino de la Princesa 68 Guayama PR 00785

Calle Boina 77 Factor 1 Arecibo, PR 00612

Mobile: 787-***-**** E-Mail: acfjev@r.postjobfree.com

progress and contract delivery dates.

Earn Value Management: Prepared project reports for both THAAD and SBIRS Programs.

Interboro System Corporation 2007 - 2008

Consulting Project Manager

Implemented Kronos Workforce Application at the Puerto Rico Department of Justice.

Technology Management: New technology implementation for this government agency.

Project Management: Led a multidisciplinary team to deliver an on time and on budget ($350K)

implementation of the “Time and Attendance, Accruals and Employee Manager Modules of the Kronos Work

Force Application.

Business Continuity: Obtain approval for second phase application implementation for $1.5MM contract

extension

Keane Consulting/ Cambridge Technology Partners/Andersen Consulting 2004 - 2007

Consulting Project Manager Elevated customer satisfaction repairing damaged relationships customer and IT

Dept, rebuilding trust and cemented loyal customer partnerships. Drive new business by infiltrating into their

operations and getting new customers as well as getting new clients.

Technology Management: New technology implementation (software development) for a major telecommunication

company and for a healthcare provider. Software development in Java, .Net and Lotus.

Project Management: Successfully completed the Puerto Rico Business Compliance Uncoupling Project on

time and within budget for a Pfizer Pharmaceutical by efficiently engaging a group of 15 consultants from three

different consulting firms by applying the risk mitigation techniques and strong leadership skills. Led a

multidisciplinary team to deliver an on time and on budget implementation of the CAPEX software at Puerto

Rico Telephone Company. Led a multidisciplinary team to deliver an on time and on budget implementation of

the eprescription software at PICA. Managed help desk as well as applications development priorities. Led the

new phone system conversion from Cisco to Interactive.

Business Continuity: Provided business solutions to Consulting clients to ensure they were able to serve their

customers better. Prepared a project Assessment which included client’s areas of opportunities, technical and

processes recommendations including ROI analysis and Risk Management.

Consulting Functional Lead and Analyst 1998-2002

Interact with customer from multiple industries to perform requirement gathering activities as well executing

programming tasks

Technology Management: New technology implementation (software development) for a major telecommunication

company (Customer Relationship Management application (PeopleSoft), Software development in COBOL for

Treasury Department, New Software Evaluation for Call Center Computer Telephony Integration Software for Major

Media Company (El Nuevo Dia Newspaper), Developed an e-Strategy for Department of Education at Bogota,

Colombia

Business Continuity: Provided business solutions to Consulting clients to ensure they were able to serve their

customers better. Prepared business case to evaluate feasibility of a New Call Center at Banco Mercantil,

Caracas, Venezuela Development Matrix for Customer Satisfaction. Performed a SWOT Analysis for the

Health and Transportation Department in Bogota, Colombia.

Schering Plough Manati Operations 2002 - 2004

Consent Decree Project Manager

Completed multiple projects of seven (7) workplan remediation quality management systems (QMS) under Consent

Decree crisis to ensure the site delivered evidence of milestones completion to FDA. This prevented the company

to pay delay fees of $15K per day until completion.

.

Project Management: Prepare and present weekly status reports and timelines to show progress of each

milestone being track under the seven quality management systems as well as support metrics assessment

and implementation for each QMS

Quality Management System: Executed Equipment/Rooms Qualification/Validation PQ for autoclaves, Ovens and

Mills for Celestone.Soluspan including management concurrence for protocol approval, sterilization, loading material,

Thanks for Keeping the team focused and engaged to ensure we complete the product launch and being able to exceed the project goal –

Recognition Card from a Direct Report

and execution. Led the Microbiology testing, results and summary report approvals.

Material Sampling System: Validated the sampling plan for raw materials. Modified SOPs to prevent Cross

Contamination and supported the revision and analysis of over 200 sampling. Support the Product Disposition

Backlog which was brought down from over 500 to zero.

Documentation System: Revised SOP to revamp the quality system to fulfill consent decree requirements

Change Control System: Revised SOP to revamp the quality system to fulfill consent decree requirements

Training System: Developed a GMP Awareness and Site Training Master Plan and modified ISOTrain System

accordingly. Implemented a feedback mechanism to monitor training effectiveness when a human error was

considered as training related. Analyst Qualification Program was developed as well as the Training system

was redesigned. Implemented Access Control System.

Compliance System: Revised SOP to revamp the quality system to fulfill consent decree requirements

Active Pharmaceutical Ingredients System: Conduct a Pareto Analysis Study to identify issues preventing

the CAPA system to execute properly and prepared a strategy to ensure the plan was executed with a quick

turnaround.

Investigation Management System: Reduce the Investigation Backlog from over 300 open investigations to

zero

EDUCATIONAL BACKGROUND

University of Puerto Rico, Mayaguez, PR – BS Industrial Engineering

University of Phoenix, San Juan, PR – MBA Technology Management

Professional Development:

Project Management Professional (PMP#1324394) Certified Green Belt (@ Honeywell)

Certified Quality Engineer @ Schering Plough Stryker Global Management Series Program Stryker Injection

Molding Academy Emotional Intelligence Academy

AFFILIATIONS

Society of Hispanic Professional Engineers

SOFT SKILLS

Great Communication Skill, Drive toward Excellence, Foster High Team Engagement

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