Project Manager

SUMMARY

Manufacturing, Project, NPI and Engineering Manager with broad electronics, aerospace and medical device industry manufacturing, R&D support and product experience ranging from start up to major implementations. Consistent accomplishments evidenced by a successful track record of devising and implementing strategies and action plans, managing resource deployment and developing team members skills. Responsible leader who builds cohesive teams, delegates responsibilities, and directs technical specialty leaders to achieve goals. Strong Knowledge in ISO 9000, ISO 13485 and FDA standards; quick to learn new concepts, oriented toward cost control so that bottom line is impacted positively and service levels are met. Fluent in English and Spanish.

PROFESSIONAL EXPERIENCE

Medtronic (04/2011 – 03/2012)

Manufacturing Engineering and NPI Director

Responsible for the strategic development, deployment and implementation of appropriate Design Reliability Manufacturing process across the site that complies with the Division Strategy, directly reported to VP Mexico Operations as Staff position.

• Responsible for the development of a site in accordance to an overall automation Medtronic strategy. Provide leadership and drive activities to ensure approved AOP programs, capital and expense budgets are achieved.

• Serve as Project Administrator for key operations projects. Responsibilities include: scheduling review meetings and establishing agendas, coordinating with Operations leadership team and project leaders on topics, pre-reads, distributing minutes, tracking action items, etc.

• Standardized the approach, practices, and methodologies for major operations projects including operations participation in new product development process.

• Guide and coach operations project leaders to develop detailed work elements, project tasks, critical milestones and contingency plans to achieve consistent positive outcomes.

• Adoption of a common methodology to support appropriate Automation Strategy.

• Initiated specific training for Operations Core Teams leaders relative to roles and responsibilities and harmonized processes and deliverables.

• Ensure Design for Lean Sigma principles are employed in all next generation programs. Develop and implement methodology to ensure harmonization, measure progress and drive continuous improvement. Facilitate the sharing of technical knowledge and the assignment of technical resources to leverage technical capabilities across the business.

• Responsible of 8 team members in Tijuana (6 Product Development Engineers, and 2 Sr. Automation Engineers), and 9 team members in Empalme Sonora facility (1 Engineering Manager, 4 Product Development Engineers, 2 Metallurgical Engineers and 2 Tooling Design Engineers).

CR Bard (06/2009 – 04/2011)

Engineering Manager

Managed high technical level Responsible for leading Advance Manufacturing Engineers, Special Projects team, Packaging Engineers, Machine Shop and Drafters, all within Urological Division; ensuring all projects are done within the design and non-design control procedures and within the established timelines. Responsible to maintain a trained and motivated engineering group. Responsible of 25 team members (2 Advance Manufacturing Engineers, 1 Special Projects Manager, 1 Machine Shop Supervisor, 1 Project Administrator, 1 Packaging Engineer Sr., 1 Tooling & Molding Engineer Sr., 1 Electronic Engineer Sr., 6 Project Engineers, 1 Tooling Design Engineer, 5 Machinists, 2 Drafters, 2 Interns and 1 Engineering Assistant), budgets @$7MM USD, directly reported to Plant Director as Staff position.

• Responsible for seen that the company design control procedures and FDA/MDD are followed during the qualification and validation of product and process changes including development testing, stabilization tests (aging), sterilization type selection, and costing analysis.

• Responsible of the qualification of product design changes, ensuring a smooth transition and implementation of such changes into production.

• 3-years plan developed including strategies and action plans to support Nogales plant vision and goals.

• Engineering restructure, initial evaluation of the engineering resources, generated a new functional organization chart and integrate two separated Engineering departments at the same time, new job descriptions generated, Career plan and develop a standard New products project procedure, templates and checklists. Generation of new metrics for Engineering and an internal score-card.

• Responsible for leading continues improving culture to increase department productivity. Coordinator of the first lean six sigma green belt certification training in-site, and part of the Projects evaluation committee.

• To identify opportunities for quality and cost improvement, a total of 4 MM USD on saving presented for 2010.

• Responsible of Advance Manufacturing Engineering group, providing technical justification, purchasing and implementation of new technologies to replace or optimize production.

• Responsible of the Machine shop department, starting from the drawing, raw material purchasing, manufacture of tooling, dies, and spare parts.

• Responsible of all the molding and extrusion equipment and product from several suppliers along USA & Mexico, evaluating maintenance, replacements or upgrades.

• Global leader of the Extrusion vertical integration project from the feasibility phase to the production released in Nogales plant, that includes the PVC tubing part numbers scope, extrusion process definition, project financial justification, resources approval (1.5M USD) and savings (more than 600K USD), machinery vendor selection, extrusion machinery: feed screws, screws, cooling system and auxiliary equipment such as: tubing cutting, winding, feeders for single & multi-lumen tubing, re-grinder, pellets feeders, selection and coordination of the raw material requirements; Technical experts selection and hire; layout design for the new operation; installation, operation and manufacturing process qualifications; responsible of the generation of maintenance manuals, coordination of training travels into Supplier facilities, spare parts definition and tooling purchase.

• Manage all the Packaging new design, changes, modifications required to improve the process, cost savings, or by regulations changes.

Avail Med/ Flextronics (03/2008 – 05/2009)

Manufacturing Engineering Manager

Managed high technical level team on Medical Device Company (KCI products), responsibilities includes: project management; schedule development; critical path assessment for project acceleration; project management training; management of assets and financial resources; technical assessment and creation of streamlined manufacturing process control systems. With a staff of 9 employees (5 Engineers, 2 Interns, 2 Documentation Clerks) and budgets of over $750K USD, directly reported to Plant Director.

• Led engineering teams on the process of qualify and release new manufacturing lines, accordingly with GMP.

• Responsible of the restructuration of engineering department, creating a new functional office for engineers group, generating career plan and training matrix accordingly with the business requirements and expectations, redirection of Engineers activities focus on lean activities and optimization of technical resources such as implementation of pneumatic and electronic testing equipment on line instead of manual tools.

• Provide intensive training on statistical basic tools theory, validation and verification documentation records, process, FDA requirements and formats to Engineers group.

• Create detailed budgets for the entire Operations department including engineers and clerks outside training, tools, and spare parts for FFS packaging equipments and running kaizen events leading by Engineers.

• Layout restructuration gaining 40,000 sq ft for new production lines and relocated some offices outside clean room and reducing the space of actual production lines by kaizen events. Giving a increasing of revenue of @ 2.3 million per year.

• Active participation on kaizen event (SHINGIJUTSU event) along one week on Cd. Juarez Chih. Flextronics plant improving the operations by the implementation of automatic testing station and giving operation saving of 800K USD.

• Responsible of the transference of a new product from KCI customer starting on the raw draft to the implementation on Mexico facility, and release on time, interacting with Avail R&D Dallas and KCI engineering group on San Antonio Tx.

Cardinal Health (05/2002 – 03/2008)

Project Manager - Lean Six Sigma Black Belt

Built department and recruited 8 engineers, 4 technicians, 5 interns; obtained financing, designed and led facilities team to build department office, lab and packaging testing area. Managed new products Department of 4 engineers, 4 support staff: budgets of over $2.5 million. Led production group of over 25 people on large project, supported existing product lines, managed laboratory and testing areas.

• Lead team from concept through development phases and production release of intravenous infusion systems projects, including generation of new fixtures or tools, implementation of new components and engagements verification and validation documentation release, BOM, Manufacturing drawings, production layout, sterilization selection (EtO, Radiation, E-Beam) and packaging selection and validation (FFS or Pouch sealed) and transportation validation.

• Ideated and coordinated interdivisional transference and implementation of new family of products from UK branch facility to Mexico plant accordingly with USA and Australia marketing requirements and regulations. Author of all necessary ISO 13485 and FDA documents (IQ, OQ, PQ) and delivered the product on time accordingly with initial timeline proposed to upper management.

• Generator of costing of all new products estimations even for USA, Europe or Oceania market, focused on customized product configurations.

• Interaction with Marketing Director, R&D team, Materials department representative, Import- export group, Buyers, Process Engineering Manager, Production manager, and Finances Manager on each single project to release a new product in the company.

• 96 new products released successfully to US and Europe market along 5 years within revenue @ 12 million per year (first year was 250K USD, increasing every year).

• Contributed to the design of new components validation studies to support the FDA 510(K) process, and participated in discussion with the FDA representative and regulation affaire department.

• Complete implementation and got the FDA authorization and release for human use of 4 new components from Australian supplier on new products to USA Marketing.

• Mexico’s representative approver on SAP of Engineering Change Notice regarding all Product, Molding and Extrusion updates from North Carolina plant and external suppliers.

• As a Lean Six Sigma Black Belt, concluded two projects focused on cost reduction with a proved financial impact of @ 500K US Dollars each one.

• Active participation on Kaizen events on Mexico plant and San Diego plants as leader and core team.

Tri-Star Electronics International (05/1999 – 02/2002)

Operations Manager

Main responsible of operation transference from El Segundo CA to Tijuana plant, hire staff and operational personnel, generator of Plant layout and starting operations on time accordingly with timeline. Responsible of manufacturing site in Mexico, (1 Supervisor, 1 Leader, 1 QA Supervisor, 2 QA Auditors, 1 shipping clerk, 1 Trainer and 75 operators).

• Achievements: Production cost reduction @ 20% on first 4 months and keep that along 1999. Turnover reduction from 28% to 6% per year. On 2002, production increase 12% and reduced cost per unit @15%.

Comair Rotron (05/1995 – 05/1999)

Manufacturing Engineer

Led interdisciplinary new products project development teams, supported manufacturing and managed custom device line. Develop methods and sequence to improve equipment capacity and product quality.

• Responsible of implementing, maintaining and improving production assembly operations.

• Support and trainer to technicians with Solder wave operation and maintenance, gun solder techniques, BGA solder and rework, SMT ovens and rosin patterns, burning rooms, harness contactors crimp tools, labeling printing, and collaborated to obtain the contract with AT&T for wireless receptors coolers, implementing Ultrasonic cleaning process, conformal coating and UV cure on PCBs.

• Facility Coordinator of prototypes and product transferences.

Mexican Navy (01/1991 – 04/1995)

Engineering / Logistic Officer

• Promoted from Petty Officer to Line Officer (Lieutenant)

• Strong personnel management on Minesweeper G-08 (more than 30 persons).

• Project leader of re-design of electronic systems on Military Vessels class "Spear".

• Trainer of Military Specifications documentation, military software packages and decoders.

• Frequently contacted sales people, suppliers and foreign engineers (US Navy & Argentina navy).

EDUCATION

• MASTER DEGREE INDUSTRIAL BUSINESS ADMINISTRATION, 2004 – CETYS UNIVERSIDAD – Tijuana, B.C.

• B.S in ELECTROMECHANICAL NAVAL ENGINEERING, 1990 – MEXICAN NAVAL ACADEMY, Anton Lizardo, Ver.

TRAINING

• LEAN SIX SIGMA BLACK BELT (training completed, Cardinal Health, Houston, TX.)

• SIX SIGMA GREEN BELT (Cardinal Health /SQE, Tijuana, B.C.)

• KAIZEN EVENT TRAINING (Cardinal Health, San Diego, CA.)

• AUTOCAD 2004 UPDATE (Engineering Systems Consulting Group, Tijuana, B.C.)

• SITUATIONAL LEADERSHIP II (Ken Blanchard Co, San Diego, CA)

• PROJECT MANAGEMENT (Kepner-Tregoe Inc, San Diego, CA)

• MICROSOFT PROJECT (Aster, Tijuana, B.C.)

• HOW TO BUILD AN EFFECTIVE TEAM (Employers Group Service Corp., Hawthorne, CA)

• ISO 9000 QUALITY INTERNAL AUDITOR (Comair/Cardinal, Tijuana, B.C.)

• CONTROL/HANDLE & CARE OF RISKY MATERIALS (Philip Environmental, Tijuana, B.C.)

• PLASTIC JOINING TECHNOLOGIES (Branson Applied Technologies Group, Los Angeles, CA)

• DMAIC for Black Belts (CR Bard, New York, NY)

• LEAN ACCOUNTING (ITESM, Tijuana, BC)

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