ERIC HULSE
Batesville,Indiana
Summary
Deep and broad experienced in manufacturing (automotive & medical), process improvement, project management, lean manufacturing, kaizen leadership and leadership role with regards to external manufacturing (contract manufacturers).
FPX (Johnson & Johnson) Project Management Certified, Certified Manufacturing Engineer, lean experienced, budgeting experience, CAPA and non-conformance experience.
Involved in myriad of roles from Packaging Engineer, Facilities Engineer, Industrial Engineer, Manufacturing Manager, Manufacturing & Process Engineering.
Adept at working internally across multiple departments as well as adept at working with external stakeholders to resolve issues and accomplish objectives.
Overview
23
23
years of professional experience
Work History
Sr. External Manufacturing Engineer
Ethicon Endo-Surgery (Johnson & Johnson Company)
2016.02 - Current
- Implemented FDA GTIN UDI Direct Part Marking for Ethicon Endo-Surgery Cincinnati, externally manufactured products (both endo-mechanical and electrical devices)
- Leading EU MDR 2017/745 implementation and compliance for all endo-mechanical devices externally manufactured by EES/Cincinnati
- Work with leadership (i.e
- Plant Management, Directors of Quality/Mfg., etc.) of multiple External Manufacturers to ensure regulatory compliance, product quality, supply continuity and continuous improvement in the supply chain for various endo-mechanical devices (processes, packaging, etc.) for myriad of externally manufactured products
- Oversee, approve, qualify and validate External Manufacturer process/product changes
- Responsible for NCR investigations and resolutions (work closely with External Quality)
- Work between R&D, PLM and External Manufacturers to successfully launch new products
- NC (ETQ), CAPA and Enterprise Change Requests, IQ, OQ and PQ oversight experience
- Supply Chain Planning (Regulatory, Sourcing, Planning) for new and obsolete code introductions into various regions and markets.
Sr. Advanced Manufacturing Engineer/Clinitron Mfg. Team Lead
Hill-Rom Company
2014.01 - 2015.11
- NPD Manufacturing Team Lead for the Clinitron Grow Project (Led cross-functional team of 12 engineers in the development of production process for Clinitron Grow Product, 55 million dollar revenue stream)
- First time in Hill-Rom history for 85% yield of a new product at Production Pilot build
- DFM&A Analysis and scoring of new R&D Designs, process development, capability analysis, process validation & verification studies (highly experienced with PFMEA)
- In-process and final test system development for new assembly Processes & products
- Job Instruction, BOM, Router development, costing analysis (make vs buy).
Sr. Manufacturing Engineer
DePuy Orthopaedics, Inc. (Johnson & Johnson) - Contract
2012.10 - 2014.01
- Originate and submit changes in Agile and SAP systems (BOM, Routers, MECR’s)
- Member of Project Rainbow (Warsaw) Core Team responsible for obtaining compliance with the FDA concerning various CFR Title 21 Part 820 issues
- Participate in the development & execution of various production process verifications, and packaging equipment validations (IQ/OQ/PQ)
- Managed the Packaging Dept
- Kaizen Program (including leading events).
Sr. Industrial Engineer
A.M. General, LLC.
2004.04 - 2011.06
- Between 2004 and 2011 reduced direct labor costs by a cumulative 6.1 million dollars
- Implemented new Integrated Armor Package drilling & assembly for HMMWV body
- Introduced many multi-machining methods throughout the Body Shop Dept
- Responsible for implementation of all process changes and new options to the floor
- Responsible for acquiring and setting up all tooling for new or altered job stations
- Implemented various Lean Mfg
- Principles and ergonomic improvements
- Lead over one dozen kaizen/rapid-improvement events throughout the plant
- My department had the least grievances with highest operator efficiencies in the plant
- Managed three direct reports (Body in White, Paint and Assembly Technicians).
Lean Manufacturing & Packaging Engineer
Zimmer, Inc.
2001.02 - 2004.04
- Developed and implemented a semi-automated packaging pilot line for endo-prosthetic hip stems, based on Lean & TPS principles
- Supervised teams in the implementation of many packaging improvement initiatives
- Sourced, purchased, installed and validated (IQ & OQ) various packaging equipment
- Conducted a myriad of time, standard and capacity studies
- Developed work standards, instructions and preventative maintenance procedures.
Education
MBA - Business Application
Indiana Wesleyan University
Marion, IN05.2011
Bachelor of Science - Mechanical Engineering Technology
Purdue University
West Lafayette, IN05.1992
Skills
- Manufacturing; Supply Chain Sustaining, Manufacturing Engineering, Project Management (FPX Certified Project Lead through Johnson & Johnson), Team Facilitation & Coordination, New Product development and introduction, PFMEA, Control Plans, Manufacturing Plans (CAPEX, estimated start-up costs, etc.), DFM&A, Lean Manufacturing, 3P, Kaizen Facilitation, Leadership, Process Analysis & Capability (Ppk & CpK), Industrial Engineering, Process Engineering, Packaging Engineering, Business Management, Six Sigma, Continuous Improvement, GMP & EU MDR (Mfg. & Quality Requirements), Training Development and Facilitation, IQ, OQ, PQ, TPS, TPM, 5S, SMED, DOE, PDCA, DMAIC, PFMEA, DFM&A and Working in Union environments.
- Minitab
- Process Improvement
- Regulations Expertise
- Risk Assessment
- Operational Reporting
- Manufacturing Processes
- Technical Support
- Process Development
Timeline
Sr. External Manufacturing Engineer
Ethicon Endo-Surgery (Johnson & Johnson Company)
2016.02 - Current
Sr. Advanced Manufacturing Engineer/Clinitron Mfg. Team Lead
Hill-Rom Company
2014.01 - 2015.11
Sr. Manufacturing Engineer
DePuy Orthopaedics, Inc. (Johnson & Johnson) - Contract
2012.10 - 2014.01
Sr. Industrial Engineer
A.M. General, LLC.
2004.04 - 2011.06
Lean Manufacturing & Packaging Engineer
Zimmer, Inc.
2001.02 - 2004.04
MBA - Business Application
Indiana Wesleyan University
Bachelor of Science - Mechanical Engineering Technology
Purdue University
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