Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Information
Timeline
Generic
JOAQUIN BELLO

JOAQUIN BELLO

Raleigh,NC

Summary

Versatile Manager specializing in Design Control, Risk Management, Purchase Finish Goods (Spec Developer) and skilled at planning, implementing and overseeing key improvements to drive compliance with regulations, business growth and efficiency. History of cultivating an open and inclusive culture with free exchange of information. Pursuing new professional challenges with a growth-oriented area in Teleflex. Strong leader and problem-solver, uses independent decision-making skills and sound judgment to positively impact company success.

Overview

32
32
years of professional experience

Work History

Global PFG Manager

Teleflex, Inc
02.2014 - Current
  • Assessment of compliance to regulations CFR 820.50 and MDR 4.5.2 for Top 30 current PFGs. Develop a scalable Design Control for PFGs that will be establish across BU in Teleflex.
  • CAPA leader for FDA 483 Design Control and Change Control/Management.
  • As Sr. Manager Quality Engineering and Risk Management (2014-2023): Provide technical and strategic leadership and subject matter expertise to R&D Anesthesia and Respiratory BU regarding Design Control, Risk Management and Design Assurance, ISO 13485, ISO 14971, 21 CFR 820, GMP Documentation and Regulations, including MDR/MDD
  • Providing leadership to Design Assurance team to support Business Units’ financials and patient healthcare goals
  • Team reporting structure located in Singapore, Malaysia, US and Mexico
  • Support design verification and validation activities of medical devices throughout product life cycle, from Concept to Commercialization, including research, development, testing, regulatory submissions, manufacturing readiness and product launch, including post-production or post-market activities
  • Work with BU and Senior Leadership to develop strategies to win market share, revenue growth, margin expansion and improve patient health outcomes
  • Due diligences participation in mergers and acquisitions and integration of companies, including divestiture of assets and product portfolio within Teleflex
  • Provide guidance and leadership to quality engineers, managing their workload to achieve excellent results for projects assigned
  • Responsible for Risk Management activities, creation and guidance of RMP, Hazard Analysis, DFMEAs, PFMEAs, RMR and Risk/Benefit Analysis
  • Manage project’s prioritization working closely with R&D, Marketing, RA, and PMO among other areas to properly support business unit goals
  • Provide adequate training, delegate and empower quality engineers on their daily activities
  • Support Customer Advocacy Team in Post-Market Surveillance activities, complaint investigation for highly visible product lines, such new product launches and purchased finished goods
  • Provide technical expertise to R&D for creation of testing protocols, statistical techniques for sample size and statistical analysis
  • Provision to Regulatory Affairs with technical documentation creation and submission in order to support agency and regulatory bodies’ submissions or device clearance
  • Support Quality Assurance with technical and design information during EIF, HHE and RE activities.

Project Manager – Research and Development

Teleflex, Inc
03.2012 - 04.2014

Sr. R&D Engineer

Teleflex, Inc
04.2008 - 03.2012
  • Responsible for New Product Development and Sustaining Engineering projects within the Respiratory product portfolio
  • Provide creative and alternative solutions to existing or new product developments, assuring safety and efficacy is uncompromised
  • Developed and maintained product Design and Development Plans
  • Support Marketing and Sales with the creation of concepts and prototypes of medical devices using Solidworks and CAD software for customer feedback
  • Responsible for the creation and documentation of testing protocols and reports during the verification and validation activities
  • Develop of Bill of Materials, routings and determination of initial COGs
  • Creation and developing of device specifications, requirements and drawings (design input/output)
  • Owner of DFMEAs, PFMEAs and support Hazard Analysis documentation
  • Prepare or coordinate formal documentation of the product design and supporting the creation of risk analysis, product specifications, market specifications according to established design control procedures
  • Investigates and resolves technical problems involving product performance, production equipment or facility systems affecting production
  • Primary liaison or interface with operations for Cost Improvement Projects, vendor materials issues and Purchased Finished Goods qualifications
  • Develop assembly methods and procedures; creates engineering draws and specifications for new product developments.

Engineering Manager, Validation, Facilities Eng

Teleflex Medical Mexico
08.2003 - 03.2008
  • Responsible of manufacturing engineering for the Respiratory and Surgical business units, coordination of product line transfers and design transfer activities
  • Process equipment validations, including facilities engineering and preventive and corrective maintenance
  • Work closely with senior management team to develop plans, timeline and coordination of the transfer and relocation of manufacturing plants into Mexico
  • Responsible for the accuracy and proper maintenance of BOMs, Routings, Product Costing and Labor rates
  • Implementation and data migration to SAP
  • Responsible to generate lean manufacturing and cost improvements initiatives, using six sigma and other improvements techniques with goal to achieve cost reduction of at least 5% VOP
  • Validation of local vendors in order to improve costs, inventory and delivery times
  • Working with R&D and Marketing during the introduction of new products
  • Responsible to assure proper process qualifications following GMP and local and global SOPs
  • Leader of the creation of Process FMEAs, Process Flows and Work Instructions
  • Responsible of developing and manage of plant and facilities layout
  • Installation and validation of device assembly and manufacturing equipment and ancillary machinery
  • Responsible for the creation and performance of preventive maintenance program.

Sr. Product and Process Engineer

Invensys Controls
05.1998 - 08.2003
  • Support manufacturing and quality activities through present product activities, research and development, lean manufacturing and cost improvements initiatives
  • Responsible of develops new applications and iterations for present products, including research, design assurance, reliability, testing and validations
  • Release and implementation to manufacturing of the new products and design changes
  • Engineering changes and document coordinator for present products
  • Coordinate the design, prototyping, costing of new products according to customer requirements
  • Six Sigma project leader, focused to improve in-process quality levels, using DOEs and other quality and statistical techniques such Gage R&R, Multivariate studies
  • Creator of DFMEA and PFMEA, support the development of Control plans and Advance Product Quality Planning
  • Product costing responsible, time and movements studies, implement Just in Time systems throughout manufacturing processes
  • Design and improvement of gauges, go-no-go fixtures, implement of electronics vision systems
  • Kaizen events leader

Quality Engineer

Delphi Automotive Systems
03.1996 - 05.1998
  • Of the creation of automotive industry product documentation, such as APQP, DFMEA, PFMEA, PPAP
  • Creation of prototype, pilot runs and advance engineering modeling
  • Responsible for the implementation of the Global Quality System in electrical wiring and stamping areas
  • Support ISO9000 certification as Quality Auditor
  • Lead assessor for manufacturing plans, creating and mapping process flows and provide training to operators, technicians and supervisors
  • Validation of test and assembly equipment
  • Perform internal assessment and audits to manufacturing plants
  • Develop the Best Practice Manual
  • Coordinate key metrics and complaint investigation, quality control data collection
  • Provided statistical techniques guidance to manufacturing and engineering during development and transfer of products
  • Participation in the development of work instructions, quality manuals, procedures and product specifications
  • Support manufacturing activities as required.

Production Supervisor

Delphi automotive Systems
02.1994 - 03.1996
  • Supervision of assembly production line of automotive electrical wiring - Responsible for the realization of production plans and achieve quality goals - Manage raw materials inventory levels
  • Balance workload for operators and machinery
  • Continuous improvement and defects prevention
  • Statistical Process Control management and analysis.

Project leader

Coca Cola, Grupo
01.1993 - 02.1994
  • For several product launches, from concept to successful commercialization, such as the Iso-Guard Drain for Breathing Circuits, Neonatal Breathing circuits enhancements and many value engineering, sustaining and cost improvement projects
  • Directly responsible for projects’ completion in time and within budget with the highest quality on the outcome
  • Responsible to form teams and provide project management support during engineering related activities
  • Assignation of each team member’s duties and deliverables, managing their time and completion
  • Identification of project’s scope, risks and ways to reduce or avoid the identified risks
  • Owner for design reviews, minute meetings and maintain an open channel of communication within and across the teams
  • Owner and creator of project’s timelines, identification of critical paths and manage risks to avoid interference of non-critical paths with it
  • Identification and manage of Key Project Indicators, ROI and administration of budget, costs and timing
  • Coordinates the reporting on project status for all responsible projects and generates reports in formal periodic project review meetings, including progress against approved schedules, capital spending and expense status., Sales and mechanical/electrical maintenance of vending machines and dispenser (post-Mix)
  • Review and analysis of sales in order to improve profitability of vending machines.

Electronics Technician

SONY
06.1991 - 12.1992
  • Manufacturing equipment preventive and corrective maintenance
  • Electrical repairs to ancillary equipment

Education

Master of Business Administration -

Texas A&M International University

BS Electronics Engineering - Electronics Technology

Tecnologico De Mexico, Nuevo Laredo
Nuevo Laredo Mexico
12.1993

Skills

  • Ability to apply and integrate knowledge of other related engineering areas to own areas of expertise
  • Ability to influence and partner with other engineering and operations/manufacturing disciplines Excellent written and verbal communication skills Good presentation skills
  • Independent thinker, strong leadership skills, ability to organize complex work, drive change and promote a culture of execution
  • Knowledgeable and practitioner of Design Control, Risk Management, FMEAs
  • Working knowledge of Minitab and tools such as Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing
  • Proficient in analytical packages (MiniTab, etc)
  • Microsoft Office Proficient (Word, Excel, Access, Visio and Outlook)
  • Proficient in PLM/ERP (including document and change control)
  • Bilingual English and Spanish
  • Experience with and understand of ISO 14971, ISo 13485, CFR 82030, 82040, 82050 IEC 60601

Accomplishments

  • Project Management, Oracle-Agile 9.3, SAP Super User, Risk Management ISO14971 UL, FDA Quality Systems Regulation 21 CFR 820, ISO 13485, UL Electrical Testing Equipment, Six Sigma Black Belt, Lean Enterprise, 8 Disciplines to Solve Problems, Total Productive Maintenance, Geometric Dimensioning, Validation of Medical Devices
  • PFMEA/DFMEA.

Additional Information

  • Additional information and references available upon request. , Page 3 of 4

Timeline

Global PFG Manager

Teleflex, Inc
02.2014 - Current

Project Manager – Research and Development

Teleflex, Inc
03.2012 - 04.2014

Sr. R&D Engineer

Teleflex, Inc
04.2008 - 03.2012

Engineering Manager, Validation, Facilities Eng

Teleflex Medical Mexico
08.2003 - 03.2008

Sr. Product and Process Engineer

Invensys Controls
05.1998 - 08.2003

Quality Engineer

Delphi Automotive Systems
03.1996 - 05.1998

Production Supervisor

Delphi automotive Systems
02.1994 - 03.1996

Project leader

Coca Cola, Grupo
01.1993 - 02.1994

Electronics Technician

SONY
06.1991 - 12.1992

Master of Business Administration -

Texas A&M International University

BS Electronics Engineering - Electronics Technology

Tecnologico De Mexico, Nuevo Laredo

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