Medical Device Engineering

JOSE M. PIETRI

***** ******* *****, **** ******, NC 27587 C.787-***-****, H.919-***-****

***********@***.*** http://www.linkedin.com/in/josempietri

ENGINEERING MANAGEMENT

Technical Leadership New Product Engineering & Development – Program Management

Medical Device – Pharma – Electronic Industries

Driven Engineering Management Professional with a B.S. Mechanical Engineering, highly successful planning,

building, and developing engineering organizations that have delivered outstanding returns. Known as a collaborative,

integrative critical thinker, always striving for methodical data driven solutions to complex operational and organizational

problems. Solid mechanical engineering background, passionate to lead, coach, and mentor technical teams. Delivers

charismatic and straightforward leadership promoting a team work environment. Bilingual: English and Spanish.

• Proven performer developing high performance teams by mentoring and coaching individuals, challenging

them to reach their full potential resulting in bottom line profits and organizational excellence.

Program Management Lead & Manage Technical Engineering Teams Change Management & Risk

Mitigation R&D into Manufacturing Mechanical Design – Six Sigma Design for Manufacturing Design

for Six Sigma Development New Process & Technology & Test Validation and Verification Clean Rooms

Dry Rooms

SELECT ACHIEVEMENTS AND ACCOMPLISHMENTS

Consulted the Pharmaceutical Industry on the assessment, re engineering plan and implementation for a GMP

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compliant raw material bulk room and other supporting processes in clean room environments.

Managed cross functional business initiatives. Reviewed Medical Device Verification program requirements

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and developed a Test plan approved by the sponsor, customers and project leads. Within a month the core team

was created with the full year plan organized. Managed the program and followed through validating all

requirements were met and expectations exceeded. This success opened opportunities for a similar program the

next year.

Transformed Medical Device design verification testing department from artistic operator dependent into

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world class automated systems. Captured internal specifications and external standards to define requirements.

Developed electromechanical hardware and software, resulted in validated automated test systems with increased

productivity and reliability (i.e. reduced Product Verification Testing critical path from 6 months to 2 weeks).

One of the systems won the Boston Scientific’s Quality Excellence Award.

Managed FDA new expectation of Implantable Medical Device accelerated time product life . FDA expected

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new products submission of accelerated time data in addition to accelerated stress data. Organized the program,

team and partnered with an external subject matter expert vendor to co develop a solution (3 months). New

products were able to submit 400 million cycle data to FDA on a timely manner.

Developed and managed the Test Method Development department budget to meet organizational goals.

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Budgeting human, material and capital expenditures. Managed $5M departmental budget, 2 groups of 25

employees, and equipment capital.

Managed large programs simultaneously. Integration of acquired Compaq R&D labs into HP Manufacturing

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(saved $20M in Q1 through manufacturing process quality improvements). Last HP Processor (Cradle to grave,

Design for Manufacturing, Technology and Process Development, R&D Proto Builds). 278 position PF DIMM

connector (vendor design, development, mechanical and electrical qualification, and implementation). Mid High

range IA 64 Server

EDUCATION/TECHNICAL PUBLICATIONS/AWARDS

B.S. (Magna cum Laude), Mechanical Engineering, 1992

University of Puerto Rico at Mayaguez

Boston Scientific Technical Excellence Award (2007)

US Patent 6903941 PCA employing a press fit connector (2005)

EAMC RELCON 2000 Press Fit Technology Paper (2000)

Mechanical components DFM for PCA’s (2000)

Application to the US Patent Office Press Fit Machine (1995 1996)

Member of NASA Pro racing Time Trials road race car.

2007 & 2010 NASA Midwest TTE Champion.

PROFESSIONAL EXPERIENCES

Independent Consultant Raleigh Durham, NC (Pharma) 2012 Present

Consulting Engineering Program Manager ( Durham)

• Assessed and developed a program to improve GMP compliance of the raw material bulking room.

• Selected new vendors and processed them onto the corporate Approved Vendors List.

• Developed and validated an automated Curing Agent Delivery System to the manufacturing line.

• Established and implemented a Preventive Maintenance program for the raw material bulking room.

• Improved syphoning process for raw materials.

• Implemented clean room Electronic Boards to facilitate tracking manufacturing progress and equipment

uptime.

Boston Scientific Cardiac Rhythm Management, St. Paul, MN (Medical Device) 2005 2012

R&D Engineering Manager

• Established functional process of excellence for the department creating a vision, mission, core values and core

purpose cascading into departmental objectives aligned with business needs on a 5 year plan. Established annual

individual objectives for each team member.

• Developed standard operating procedure, established framework to build robust solutions to achieve our vision.

Broke ground by standardizing the process to attain consistent statistical bound results (95% confidence 99.9%

reliability) beyond FDA highest required levels.

• Steered the culture to focus on automation and six sigma as the solution for consistent high first pass yields,

reduced test false failures, and overall process robustness with high confidence and reliability. Enforced a sense

of urgency for Safety which resulted in the development of operator safe systems compliant with OSHA and

internal EHS regulations.

• Manage Test Method Development engineering group (11 employees) and Design Verification Testing group

supporting all Product Design Departments (10 employees across 9 development labs).

• Planned and implemented Clean and Dry Room Laser and Resistance weld line replication plan which resulted in

$2M capital investment that brought high flexibility to run more product families simultaneously that more than

doubled product output.

Hewlett Packard, Aguadilla, PR (Electronics) 1995 to 2005

New Process & Technology Development Program Management

• Relationship builder with merged labs, managing product transfers, adapted them to HP processes. Solved quality

issues by improving manufacturing processes with new technologies saving $20M in Q1.

• Process Program Manager for New Product Introduction (Lead NPI teams of 10~15 engineers). Process Project

Manager for HP/Intel IA 64 programs (Lead team of 10 engineers) – Resulted in on time Processor readiness for

new Servers product portfolio of IA 64 Platforms.

• Established Hewlett Packard’s Mechanical components Design for Manufacturing guidelines for Printed Circuit

Assemblies. Led the development of all manufacturing processes for the last HP processor generation ensuring

compatibility with the Intel’s portfolio of IA 64 Platforms.

• Designed, developed, and implemented new processes and equipment into manufacturing environment. New

Generation Solder Paste qualification – elimination of nitrogen as prime material solder processing $3M/year

cost of goods savings. Created Press Fit Process and Equipment at HP Puerto Rico and implemented at HP Fort

Collins, SCI Colorado Springs, and EMS Mayaguez, PR. Application US Patent Office for Press Fit Machine

(1995 1996). Two new SMT Lines Project Management ($5M in capital equipment).

Avon Products, Aguadilla, PR 1994

• Productivity Improvements through Six Sigma

• Managed multiple simultaneous (29) projects to improve productivity – Over $1M in savings the first year.

Machine shop supervisor (3 tool & die makers). Managed 2 full time project engineers and the engineering

student program partnering with University of PR Engineering School (16 Mechanical engineering students).

• Optimized plant HVAC systems by determining current load demand. Resulted in power savings by reducing

amount of units from 14 to 8 with a new air ducting design.

Motorola, Vega Baja, PR 1993

• Surface Mount Process Engineer, Six Sigma and Standard Process Control (SPC).

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