Medical Extrusion Consultant -
Peter Turk

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Medical Extrusion Expert Peter Turk

Peter has more than 28 years in the medical device market. Manufacturing engineering support. Research and development into new and/or improved polymer processing, manufacturing and extrusion production methods. Management of projects related to the development of medical devices and accessories. Setup and validation of extrusion and clean room activities. Certified Green Belt.

PROFESSIONAL EXPERIENCE
 
July 2019 - May 2021
Stryker Neurovascular, Principal Extrusion Engineer
Salt Lake City, Utah   

• Support transfer of extrusion manufacturing operations to SLC site from California
• Development of Extrusion program including cost improvement and process improvement programs
• Validation of new products
• Supported the development of an internal R&D program.
• Support organizational/department operations such as NC/CAPAs, pFMEA development, and other miscellaneous production documentation creation and updates
• Implementation of SPC packages on laser gauging systems as part of the documentation package.
• Replacement of on-line gauging with toolmakers microscopes with state-of-the-art vision system with statistical reporting to replace manual x-bar R charts.

 
August 2017 – April 2019
Medron/Flexan, Manager Extrusion, Technical Services
Salt Lake City, Utah

• Managed extrusion operation for Flexan
• Worked with customers and sales on the development of extruded products
• Developed processes for extrusion of TPU, TPE, PEBA and polyolefin materials and blends
• Set up and validated 1-inch extrusion line for single and multi-layer extrusions
• Set up and validated 2½ extrusion line for PVC extrusion
• Executed all equipment installations, IQ and OQ’s and all supporting manufacturing documentation such as Manufacturing Instructions, Inspection documents and FMEAs
• Development of braiding program
• Trained technicians on extrusion processing and inspection techniques
• Managed department Safety Program

 
May 2015 – June 2017
Merit Medical, Senior Engineer
Houston, Texas 

• Supported extrusion, material compounding and braiding operations
• Implemented improvements to extrusion processes and test methods
• Worked on improving existing twin screw compounding screw inventory as well as installation of a second compounding line.
• Worked with the Team on issues related to materials compounding and materials source (radio opacifiers).
• Development and implementation of tooling control system
• Managed NCMR and CAPA program for extrusion department

 
2007 – May 2015
Medtronic Cardiovascular, Principal Extrusion Engineer
Santa Rosa, California          

• Support the Extrusion Manufacturing Operations for Medtronic’s Cardiovascular Division
• Implemented process improvements that resulted in savings in excess of $1million annually
• Supported Lean Sigma program developing and validating new balloon tubing extrusions
• Implemented Lean programs to improve productivity of extrusion operations
• Certified Lean Sigma Green Belt. Managed and supported DMAIC projects related to processes
• Worked with customers on the development and validation of catheter tubing
• Development of documents, standards and procedures for product manufacturing and test methods
• Development and implementation of extrusion tooling control system
• Extrusion system development and implementation
• Support on the investigation and closure of NCMR’s and CAPA’s
• Investigations into product performance related issues through use of various polymer analysis techniques
• Managed Environmental, Health and Safety Programs in Extrusion Manufacturing Department

 
2002 - 2007
Terumo Medical Corporation, Senior Mfg. Development EngineerElkton, MD   

• Set up extrusion and materials compounding program to manufacture reinforced (braided) tubing for introducers and guiding sheaths
• Developed, managed and implemented program for continuous improvement of existing processes
• Development of test methods and protocols for the evaluation of catheter prototype performance
• Development of new materials and processes for dilators and guiding sheath catheters
• Investigations into product performance related issues through use of various polymer analysis techniques
• Development and validation of processes for manufacturing catheters
• Managed OEM program for the development of catheter sub-assembly for in-house product final assembly Developed all support documentation including specifications and validations
• Development of Design Control Protocol/Procedure that defined activities necessary to bring product from concept to final approval.  Development of Hazards Analysis procedure

2000 - 2001
Novoste Corporation, Senior Manufacturing Engineer
Norcross, Georgia                      

• Set up and commissioned new clean room at manufacturing site outside of Glasgow, Scotland
  • Purchased, installed, and validated (IQ, OQ, PQ) processing equipment that included tipping, bonding,
  • Skiving and other catheter related manufacturing processes.
  • Installed Nitrogen generation system to replace the nitrogen cylinder system.
  • This included purchase and IQ/OQ/PQ of catheter manufacturing and testing equipment.
• Supported development of next generation brachytherapy catheter products
• Developed and validated new manufacturing processes for catheter assembly
• Revalidation of sterilization process.
• Updating of manufacturing procedures as well as improvements to related processes.
• Supported development of insert molding of ISO compliant luer fittings to tubing.
• Validated Instron test method for product testing.
  
  
  

1993 - 2000
Boston Scientific/EP Technologies

1998-2000
San Jose, California                                            
Manager, Cables, Sheaths and Accessories                                                  

• Managed program and cross functional Team from initial product justification to final approval for the design and manufacturing of Introducing Sheaths to support EP catheter delivery
• Managed cable accessory program. Developed an offshore program with a contract manufacturer that resulted in an annual savings of over $1 million, or 30% cost savings·
• Managed program for Pericardioscentesis Kit. Resulted in 20% savings through the use of new vendors and the design and development of in-house capability to manufacture drainage catheters 

1993-1998
Extrusion and Process Manager                                                                       

• Set up extrusion department and developed extrusion capabilities
• Managed Extrusion Department supporting production and research and development programs
• Validated OEM vendors to support supply of accessories (cable assemblies and introducing sheaths)
• Supported design and development of next generation electrophysiology catheters
• Set up and validated extrusion and braiding operations at EPT
• Developed new braided tubing for electrophysiology catheters
• Member of Polymer Processing and Science Council
• Development of resin lot specifications based on polymer analysis techniques such as rheological characterization

Experience prior to medical device industry noted above

A and E Plastics (@ 1 year)

• Supported manufacturing projects related to BOPS (Biaxially Oriented Polystyrene) extrusion and thermoforming for food packaging.
• Design and upgrades to BOPS line equipment from front to back
  • Extrusion material handling, extruder design, in-line orientation sheet roll stack, tenter frame, nuclear gauging, take-up design, etc.
  • Upgrades from older heater controls to newer PID controllers for downstream equipment.
  • Supported PS scrap reclaim - design of underwater pelletizer die and downstream handling for reclaim/pelletizing of PS.
  • Materials handling system to move scrap from extruders and thermoformers to reclaim extruders.
• Support for polymerization of PS in-house.

​Advanced Web Technology (@ 1 year)

• Managed Team in the development and installation of web handling systems for aerospace composites such as coaters, curing ovens, slitters and accumulators.
• Managed projects with outside vendors and suppliers.
• Developed novel coating systems for graphite and Kevlar fiber bundles.

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​Avery Research (@ 2 years)

• Development of an extrusion program for the development of label and tape concept for their Corporate R&D group.
• Development of lab extrusion line to evaluate backings for label stock.
• Materials and coating development.
• Die design for sheets and custom tapes.

Raychem Corporation (Corporate R&D, Wire & Cable, @ 7 years)

• Development of compounding capabilities on co- and counter rotating twin screw extrusion equipment.
  • Included design and setting up screw removal and disassembly techniques, and development of an equipment maintenance system
• Materials development for the introduction of both heat shrink and poly-switch products.
• Radiation chemistry through use of E-beam and Cobalt 60 radiation sources.
• Development of novel multi-layer extrusions that led to 2 patents in product design.
• Supported extrusion development of underground fuel leakage sensor and cathodic protection systems.
• Development of fiber spinning and fiber optics coating extrusion techniques.
• Tooling design for sheet and profile (tubing) extrusions.
• Moved from drawing board to first main frame supported CAD programs.
• Development of rheological capabilities and studies
  • Developed slit die rheometers for online theoretical studies
  • ​Performed studies on Rheometrics DMA rheometer
  • Developed and upgraded capillary rheometer for an Instron (before they offered one)
  • Authored two SPEW ANTEC papers related to rheological studies
  • Note: much of this work was in support of Dr. Chris Rauwendaal in his theoretical studies in polymer melting and screw design for his first publication

Die, tooling, and equipment design activities (various companies)

• Extrusion crosshead designs (single and mutli-layer), novel designs for processes such as fiber coating and braided extrusion coatings
• Novel crosshead designs for coated fiber reinforced tubing applications (3-6-inch diameter elastomeric pipe).
• Sheet die designs. Novel 2 material side by side extrusion head. Coextrusion sheet dies (w/feed blocks).
• Novel rheometers for material studies.
• Blown film designs
• Unique widgets and gadgets to support extrusion lines
  • Pay-offs for fibers and braided extrusion coatings
  • Custom take-up system for hard to handle materials (such as low durometer urethanes)
  • Preheat stations
  • Braider staking heaters
  • Slicking die assemblies
  • Wire straighteners
• Development of tooling control systems, mainly for medical device manufacturers.

Materials failure analysis

• Use of various analysis techniques for troubleshooting extrusion related issues
• Rheology, both Capillary (high shear) and DMA
• MWD determination (GPC) and data analysis
• FTIR, TGA, DSC and other techniques
  
  

Safety Management

• Managed safety program for extrusion lab that ran 24/5 with about 80 employees and 18 production and R&D extrusion lines as well as support processes such as heat shrink and coating operations.
• Supported safety program in disposal of bad chemicals used in development of adhesives (NFPA ratings of 3& 4).
• Audit specialist in reviewing and recommending updates to workspaces/labs.
• 5S and Lean Sigma experience in implementing safety improvements.
• Supported and developed programs to improve employee engagement in safety
  programs.
• MERT Team member with 1 st response experience.

EDUCATION

• California State University, Chico, Bachelor of Sciences, Industrial Technology

SPECIAL COURSES

• Lean Sigma Green Belt
• Advanced Extrusion
• Rheology
• SolidWorks Basics
• Radiation Dosimetry
• Management Communications
• ISO 9001 Lead Auditor Certification
• Dale Carnegie Presentation Skill
• Insight Out Medical Devices Training
• MERT and CERT Training

AFFLIATIONS

• Society of Plastics Engineers, Past President, Baltimore-Washington Section
• Society of Plastics Engineers, Past Vice-President, Golden Gate Section
• Past Member, Manufacturing Technical Advisory Board, California State University, Chico
• Past President and Board Member support to non-profit organization (Windsor Arts Council)

 
PATENTS, PUBLICATIONS & AWARDS

• Two patents awarded related to Rapid Exchange catheter design
• Two patents awarded related to Towed Array Sonar Sensor design
• Two papers published at SPE ANTECs related to polymer rheology
• 2010 and 2013 Star of Excellence Awards for cost savings programs at Medtronic
• Nominated to Stryker STAR reward as part of Production Transfer Team

INTERESTS

• Motorsports, especially Formula 1 and any other high technology motorsports
• Artist
• Science Fiction
• Fantasy
• Steampunk art