Engineer Medical Device

JOSE R. COLON FREYRE

**** ****** ** **** ***

Simi Valley, CA 93065

Phone: 805-***-****

E-mail: *************@*****.***

OBJECTIVE

To continue my professional growth with an industry leader in pharma, biotechnology and/or

combination devices that give me the opportunity to utilize my technical, managerial and operational

excellence dexterity to implement process solutions aligned with company goals.

SUMMARY OF MAJOR ACCOMPLISHMENTS

• As Principal at Amgen Corporate HQ I have been able to directly influence the Manufacturing of

the Future (MoF) structure while striving towards global harmonization of technologies including 21

CFR Part 11 Compliance and Serialization. My leadership has resulted in smarter ways to spend capital

resources achieving regionalized goals with shorter lead times, reduced capital expenditures and less

complexity while still meeting Amgen’s high quality and business standards. My position was newly

created when on boarded. Quickly grew from 1-Man-Band to a team of Engineers directly responsible

to support aggressive NPI, Amgen’s Full Potential initiatives, global expansion and existing sites

initiatives.

• As the Global Product Transfer Manager at Biomet 3i I supervised a cross functional team

dedicated to the implantable devices introduction and transfers to Europe and Asia by developing the

new sites manufacturing and quality processes to attain high quality finished medical device

manufacturing while building strong regional and global supplier relationships and standardizing with

existing operations at the Palm Beach Gardens site.

• As Medical Device Program Manager at Vaupell I oversaw the Medical Device Business Unit,

by managing the attainment of ISO 13485:2003 and re-structuring the Engineering Department

introducing the New Product Introduction (NPI) stage gate concept to streamline team’s capabilities

supporting the medical device design, molding, assembly, packaging and sterilization processes. I was

responsible for internal and client DMR support and traceability matrix adherence.

• As Process Development Engineer at Amgen Biotech I contributed to the growth of the vial,

prefilled syringe and combination device manufacturing capabilities. Oversaw NPI and process

improvement functions from equipment procurement, automation, validations and manufacturing

operational excellence. Performed as the Subject Matter Expert in high speed Vial, Syringe and

Combination Devices manufacturing processes.

• As the Sr. Manufacturing Engineer at Becton Dickinson I supervised the product transfer of the

Bard Parker® surgical blade products from USA to P.R. The transfer included procurement, new site

development, training of personnel on operations such as machining, cleaning, inspection, electro-

polishing, assembly, packaging and sterilization.

• I contributed to numerous high profile projects such as Aranesp®, Enbrel®, Safety Flow® and

QuikHeel®, contributing to sound manufacturing launches and sustainable manufacturing operations.

SKILLS

Technical Expertise includes:

• 820.30 Compliance expertise

• Serialization- Planning, Execution and Program Implementation

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• Process improvement using 6 Sigma and lean manufacturing techniques, such as FMEA, DOE,

SPC techniques, to mention a few.

• All stages of the manufacturing industry from Voice of the Customer to product deployment in a

wide array of biotech (small and large molecules) and combination device type products.

• Detailed User Requirement Specifications with working knowledge of UL, NFP and CE

Machinery directives.

• CFR, cFDA and ISO guidelines.

• Implementation of Stage Gate Process to support successful NPI’s

• Development of sustainable NPI cost effective manufacturing processes.

• Engineering economics including capital requisition/ justification, resources management and

site layouts and quality system management.

Managerial Expertise includes but is not limited to:

• Strategic management of cross functional teams across the globe.

• Experienced managed cross functional teams of over 10 direct reports across multiple sites.

• Negotiation skills and partnership development with internal and external suppliers.

• Hands on know-how of program management of multiple resources, understanding the

intricacies of delegating and facilitating tasks as needed to succeed.

• Mentoring of resources across the globe, including China, Taiwan, P.R. and Spain towards

enhanced and sustainable execution.

• Believer of hands-on work and attention to detail.

• Excel at establishing individual development plans with direct reports to assure their measured

growth.

Interpersonal:

• Cultural Dexterity on how to bridge the gap of when working with different cultures

• Fluent in English and Spanish.

• Excellent interpersonal skills gaining respect by show of hand.

• Well respected Mentor and Facilitator.

PROFESSIONAL EXPERIENCE

Amgen Thousand Oaks, CA

February 2012 to Present

Process Development Principal Engineer (Level 6 eq. Sr. Manager)

• Lead of the Process Development Global Equipment Engineering Team responsible to

implement new technology assuring the proper design, qualification and implementation of

equipment and processes to support aggressive NPI, global expansion and existing sites

initiatives. Subject Matter Expert (SME) supporting the review and assessment of new

manufacturing process equipment and processes, Design, Qualifications, Characterization, and

Operational Compliance Requirements in alignment with site selection. Role also supports the

commercialization and operational guidelines/procedures across multiple sites to assure proper

harmonization.

Biomet 3i PBG, FL

October 2008 to February 2012

Global Product Transfer Manager

• Managed the deployment and implementation of product transfers to Asia and Europe.

Responsibilities included overseeing interaction of the global multi-disciplinary groups to

successfully transfer new and existent products.

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• Supported development of the new sites from conceptual layout to finished medical device

manufacturing and packaging while building strong regional and global supplier relationships.

Vaupell Medical W. Springfield, MA

August 2006 to October 2008

Medical Device Program Manager

• Manager dotted line report to C.O.O., responsible for the development and deployment of the

medical device manufacturing and quality control systems, such as the New Product

Introduction system and Master Validation Plan, to support design, molding, assembly and

packaging operations for a diverse medical device and components customer base.

• Managed all new medical device product introductions and transfers.

• Managed the Class 8 cleanroom manufacturing operations, including cGMP training and

development of the sanitizing program.

Amgen Biotech Juncos, P.R.

April 2003 to August 2006

Engineer III- Product/Process Development Engineer

• Accountable of the justification, capital requisition, procurement, project management and

implementation of device, vials and syringe manufacturing systems for current and new product

introductions.

• Subject matter expert in Vial, Syringe and Combination Device Assembly Automated Systems

• Accountable for Fill & Finish CAPA and Non-Conformances Projects.

Becton Dickinson Multiple Sites from 1997-2003

September 2001 to April 2003

Sr. Manufacturing Engineer Becton Dickinson Surgical-PR

• Sr. Engineer responsible of Bard Parker ®Surgical Blades Manufacturing operations transfer to

P.R.

March 2000 to September 2001

Project Engineer Becton Dickinson Medical-CT/NJ

• Responsible for leading project driven teams in the implementation of six sigma and lean

manufacturing methods. Trained as Six Sigma Black Belt by the Juran Institute for Becton

Dickinson’s 2nd Six Sigma Deployment Wave.

• Engineer responsible to lead and/or be part of multi-disciplinary teams for the implementation of

new product lines and re-engineering of existing ones.

April 1997 to March 2000

Manufacturing Project Engineer Becton Dickinson Pre-Analytical-PR

• Engineer directly responsible as the manufacturing liaison for the R&D personnel, for all product

manufacturing tasks related to the start up of all Next Generation Microtainer® Brand Tubes

chemistry line new products (SST, PST and Glucose), including machine procurement,

acceptance and installation.

EDUCATION

Western Governors University

Credits towards MBA in Strategic Management with graduation expected FY15Q2.

University of Puerto Rico, Mayagüez Campus, PR

Bachelor of Science in Mechanical Engineering, Graduated December 1996

SEMINARS

• Cultural Dexterity and Country Immersion Amgen

• Leadership Effective Training (L.E.T.) Vaupell

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• Six Sigma Black Belt Training Juran Institute / Becton Dickinson

• KAYE Temperature Validator User Training INSCO

• Train the Trainer Riutort Transformation

• Failure Mode and Effect Analysis Becton Dickinson

• Calibrations New Standards for ISO Becton Dickinson

• Statistical Process Control (SPC) Wayne Taylor Ent. Inc.

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Phone: 805-***-****

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