Engineer Injection Molding

NEFTALI FERNANDEZ

Moreno Valley, CA ***** 719-***-**** ************@***.*** https://www.linkedin.com/in/neftalifernandez/

EXTRUSION & MEDICAL DEVICES Subject Matter Expert (SME), PROCESS ENGINEER

R&D core team member of the next generation catheters for dilatation, stent delivery system, Neurovascular and Pacemaker leads extruded components. Developed and validated new extruded parts that were used to launch new product such as pacemaker leads and leads delivery system, Neurovascular catheter, Electrophysiology catheter, Coronary Dilatation catheter, Structural Heart (Mitral valve repair) catheter and Stent Delivery System catheter. Have comprehensive knowledge of polymer & resin properties requirements for catheter performance specifications. Development of innovated extrusion processes and extruded product to enhance the catheter performance and reduce manufacturing cost.

Catheter assembly process development and validation (tubing necking, braiding & coiling, shaft assembly, balloon bonding (laser or hot box), and hydrophilic coating.

Extrusion, Injection molding, twin screw compounding, Blow molding, Blown film, and Angioplasty balloon forming.

Equipment and process validation.

Shrink tubing extrusion process and expansion development and validation.

Braided extruded part centerless grinding process development & validation.

Extruded part measurement system analysis (MSA) development & validation

Development of polymer compound formulation for catheter performance enhancement.

Manufacturing suppler development & validation for extruded tubing, injection molded part and compounded resin.

Over 25 years working with medical devices in compliance with GMP, ISO 13485, 21 CFR Part 11 & Part 820, ISO 9000, and similar standards for FDA Compliance.

Bilingual (English and Spanish).

SPC Certificate SolidWorks Excel Word Power point Microsoft Project Six Sigma Green Belt Certificate & DOE Certificate Minitab JMP

PROFESSIONAL EXPERIENCE

MICROVENTION, Terumo Aliso Viejo, CA 2018 - 2020

Staff Engineer

Managed an engineering and technician team (3 associates) to support catheter production and new process/product validation.

Managed the development of catheter processes improvement for the final product characterization and validation that improve the yields from 80% to over 90%.

Managed and implemented the development and qualification of new equipment to support production business growth and improve current processes.

Managed the transfer of several production lines to another site to increase production capacity and business flexibility.

Administered validation of innovating catheter subassembly fusing technology that reduced manufacturing process over 60%, reduced handling over 50% and over 10 % scrap reduction.

Managed supporting (material specification, equipment validation, documentation) the R&D and production engineering team on plastic part process parameter and condition requirements.

Managed supporting the quality engineering team on NCRs and CAPA on internal and external product issues.

Managed extrusion and injection molding technical support for the suppliers manufacturing engineering team.

SPECTRANETICS CORP. Colorado Springs, CO 2017 - 2018

Extrusion Engineer Manager

Managed the extrusion department production and inspection team (14 employees) daily activities to support catheter production.

Managed the development of extruded tubing processes for the product characterization and validation.

Managed the budget, development and qualification of new equipment to support the extrusion business growth and improve current processes.

Administered problem solving techniques for extruded tubing processes to help reduce catheter production scrap.

Manage the technical investigation to support the quality engineering team on NCRs and CAPAs related to internal and external extruded product issues.

Manage the technical support to help the metrology team in developing extruded tubing inspection tools, equipment and techniques for test method validation.

Managed extrusion and injection molding technical support for the suppliers manufacturing engineering team.

Extrusion Engineer (Self Employed) 2016 - 2017

(SME Consultant) for SPECTRANETICS CORP

Supported the development and qualification of new equipment to improve the extrusion current processes.

Developed the implementation of refined extrusion processes (DOE) to improve the in house extrusion technology for the validation of all the extruded tubing.

Administered the implementation of the extrusion techs cross training program to support process validation. As a result, the tubing quality improved, production backorder dropped and 100% inspection eliminated for high volume extruded tubing.

CONFLUENT MEDICAL, Laguna Niguel, CA 2015 - 2016

Extrusion Engineer Manager

Managed the extrusion team (6 employees) to support the daily production of tubing for external and internal customers.

Managed the development and qualification of new equipment to support the extrusion business growth and improve current processes.

Managed customer interaction to review extruded product specifications, cost and finish device requirements.

Administered the budget for new equipment required to grow the business, improve production capacity and product quality.

CREGANNA, Campbell, CA 2014 - 2015

Sr. Extrusion Engineer / Supervisor

Managed the extrusion department team (9 employees) for the production and R & D of extruded tubing processes for CDC balloons, neurovascular catheters, structural heart delivery systems, leadless pacemaker delivery systems and validation of AAA catheter stent delivery system.

Administered a production scheduling plan that increased extrusion capacity 50 percent and reduced manufacturing back orders to zero without the use of over time.

Administered the implementation of improved reflow over the braided shat process that increased the yield by 30%, reduced over time by 50%, reduced ergonomic issues and eliminated back order.

Managed the development and qualification of new equipment to support the extrusion business growth and improve current processes.

Administered the implementation of refined extrusion processes to improve the in house extrusion technology. As a result, the balloon blowing productions improved the yield from 60 percent to over 90 percent, reduced customers’ complaints from 70 percent to less than 5 percent, in addition other products such as Neurovascular and balloons had an increased yield of 15 to 30 percent.

Administered the innovation of a new tooling drawdown ratio design to simplify the multi-lumen extrusion process and reduce the extrusion runs necessary to meet the tubing specs.

MEDTRONIC, Santa Rosa, CA 2012 - 2013

Sr. Material Engineer R&D

Managed the Research & Development, validation and documentation of polymer compounds, extruded tubing processes for the next generation coronary and hypertension ablation-therapy catheters.

Administered the implementation of refined extrusion processes (equipment setup and polymer preparation) to improve the in house extrusion technology.

Managed the extrusion R&D project for the validation of a coronary aspiration catheter.

ABBOTT VASCULAR, Temecula, CA 2006 – 2012

Sr. Extrusion R&D Engineer

Administered the Research & Development, validation and documentation polymer compounds, extruded tubing processes for the next generation dilatation and stent delivery catheters.

Administered the extrusion process innovation of braided extruded shaft technology (equipment setup and personnel training) for Endovascular Solution self-expending stent delivery system.

Managed the extrusion process innovation (patent granted) of dual polymer layers taper shaft for OTW catheters, stent delivery system and extrusion R&D project for the Rx/OTW next generation CDC.

Administered the implementation of a new three polymer layers tooling to improve the in house extrusion technology by facilitating the process setup and homogeneous tubing layers construction.

BIOSENSE WEBSTER INC., A JOHNSON & JOHNSON CO., Diamond Bar, CA 2003 – 2006

Sr. Extrusion Production & Development Engineer

Managed Research & Development (R&D), validation and documentation of polymer coated braided single & multi lumen tubing for diagnostic and therapeutic electrophysiology catheters.

Managed the Implementation of Innovating braiding technology that increased production capacity, improved product quality and reduce cycle time by 50%.

Administered and developed a new wire mandrel coating process conditions that helped increased production yield by 26 % and mandrel price reduction of 17 %.

Managed the development and qualification of refined air mandrel process technology to replace the current over the wire process that decreased the cycle time from 40 hr. to 8 hr, saved over $380K per year in cost of wire and significant reduction in ergonomics. (Green Belt Six Sigma Project)

Managed the development of refined centerless grinding process technology that reduced the extruded part finishing cycle time by 40% and eliminated environmental & ergonomic issues.

Managed the extrusion R&D, validation of new extrusion process & braiding technology for the production and development of electrophysiology catheters with magnetic steering technology.

Administered R&D of new polymer formulations and extrusion process conditions for the electrophysiology catheter Tip.

Managed the budget and CIP of the new high tech multi-mandrel coating line for the production and development of braided extrusion.

Managed the development of supplier’s quality improvement plan, for the resin compounding specs, braiding material, mandrels technical supplier assessments.

GUIDANT CORP., Temecula, CA 2000 – 2003

New Product Development Engineer

Managed the R&D, validation and documentation of Polyurethane tubing and fluoropolymer coated fine wire for the production Pacemaker/ Defibrillator Leads.

Managed the innovation of Polymer Melt Pump Technology for Next Generation of Leads Tubing.

Administered and developed a new manufacturing process conditions that helped increased production yield by 15-30 %.

Managed the R&D and qualification of new technology for the production and development of polymer coated fine wire for the Pacemaker Leads.

Managed the project for the new high tech wire coating line for the production and development of fluoropolymer coated fine wire for the Pacemaker/Defibrillator Leads.

BOSTON SCIENTIFIC, Natick, MA 1996 – 2000

Process Engineer (R&D)

Managed Research and Development of next generation of single and multi-lumen catheter shafts, balloon tubing, tapered variable stiffness catheter shafts, multi-layer fiber braided catheter shafts and extruding over different wire sizes.

Managed the set-up of daily experiments, documentation, performing high pressure test on the catheter shaft, selecting resins based on the properties requirement for new catheter sub-assemblies.

Managed the implementation of new ideas, problem solving, and supporting the extrusion department on the development of new products, modification and validation of the extrusion line and tooling design.

Administered the documenting of daily experiments and catheter shafts performance test in lab notebook.

Administered the creation of measurement computer programs for SPC purposes.

Administered transferring products and extrusion process technologies to other sites.

EDUCATION

Bachelor of Science, Plastics Engineering Technology, University of MA, Lowell, MA

AWARDS

Biosense Webster Inc., a J&J Co, Standard of Leader Ship Award and Business Values Results Award.

Department of the Army, the Army Achievement Metal.

PATENTS

US 8,298,466 B1 Method for Fabricating Medical Devices with Porous Polymeric Structures.

US 8,444,608 B2 Robust Catheter Tubing.

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