Experience

Providence Medical Technology, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Manufacturing Engineering Manager

  • Mar 2019 - Present

  • Technical Product Manager for commercially released products. • Develop & align department initiatives with strategic objectives. • Oversee the workload and workflow of the department; sets priorities for the team based on company objectives. • Lead Manufacturing Engineering continuous improvement efforts to improve processes, product quality, process quality, lead times, as well as lead cost reductions. • Manage Product Transfer and New Product integration projects. • Lead development of manufacturing process, equipment & fixturing and associated documentation. • Manage contract manufacturers (CMs), upstream suppliers and internal cross functional teams to improve product DFM, reduce process risk and increase throughput. • Evaluate and develop innovative solutions to complex product and production problems through identification and implementation of advanced manufacturing processes. • Manage Contract Manufacturers (CMs) throughout the manufacturing and assembly process. This includes management of production NCRs, ensuring smooth process flow and verifying adherence to QMS documentation requirements. • Ensure completion of equipment qualification and process validation (IQ, OQ, PQ, PPQ) as well as provide training to appropriate CM resources on Standard Operation Procedures and Work Instructions for new manufacturing processes and equipment. • Work with Quality to ensure completion of biological testing pertinent to product development and manufacturing product transfers. • Evaluation of line efficiency, cycle time, and TAKT time. • Provide input to R&D on Design for Manufacturability (DFM). • Support field failure analysis to determine root cause(s) and implement corrective action(s). • Monitor product quality performance through manufacturing data such as yield, rework, NCR's and by applying statistical process control (SPC) and CPK analysis where appropriate. Show less



St. Jude Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Manufacturing Engineer

  • Oct 2015 - Mar 2019

  Technical Lead of Manufacturing Line transfer PHP Wiring/Tubing Harness -Specified All equipment for MFG line -Designed Simple Fixtures -Managed Completion IQ/OQ/PQ of all fixtures -Mentored and Developed Engineers -Physically installed MFG line in CER -Oversaw PV build passed first attempt under extremely tight timeline Technical Lead of Manufacturing Line transfer PHP Wiring/Tubing Harness -Specified All equipment for MFG line -Designed Simple Fixtures -Managed Completion IQ/OQ/PQ of all fixtures -Mentored and Developed Engineers -Physically installed MFG line in CER -Oversaw PV build passed first attempt under extremely tight timeline



Thoratec

• Computer and Network Security
• 1 - 100 Employee

• Senior Manufacturing Engineer

  • Feb 2014 - Feb 2019

  Technical Lead for Injection Molded Plastics Supplier Support projects. Technical Lead for Injection Molded Plastics Supplier Support projects.


BioCardia
• United States
• Biotechnology Research
• 1 - 100 Employee
• Senior R&D Engineer

  • Nov 2011 - Jan 2014

Access Closure
• R&D Engineer 2

  • Jun 2008 - Nov 2011

EV3, FoxHollow Division
• Research and Development Engineer 2

  • 2007 - Jun 2008

Fox Hollow Technologies
• Medical Equipment Manufacturing
• 1 - 100 Employee
• R&D Engineer

  • Jan 2007 - Nov 2007

Novellus Inc
• United States
• Biotechnology Research
• 1 - 100 Employee
• Supply Chain Analyst

  • Aug 2006 - Jan 2007

NUMMI
• South Africa
• Financial Services
• 1 - 100 Employee
• Process Engineer Externship

  • 2005 - 2005