STEVEN L HENDERSON, CPM

Product Design / Sustaining Engineer
Loveland, Ohio
contact:
shender4@fuse.net

 SUMMARY

Accountable Leadership. Value-Based Optimization through Design Effectiveness

Project engineering professional with creative, resourceful and organizational skill sets in Product Development and Product Life Cycle management for the medical and consumer markets.  Experiences range from successful startup businesses to contributing to Fortune 100 companies which have prepared me for most challenges at any production and sales volumes. Reputation as a passionate driven leader for product realization and project completion while promoting quality system compliance and business value as priorities. 

Core Competencies:

Leadership

Design

Manufacturing & Operations

Quality

- Project Management
- Team Player, lead by example
- Cross Functional Leadership
- Problem Solving
- Action Plan Development /  Milestone Definition
- Professional Mentoring

- DFM&A- GD&T (ASME Y14.5M-1994)
- Dimensional Stack-up 
   Analysis
- Prototype Creation
- SolidWorks
- Pro/Engineer
- Adobe Illustrator

 

- Equipment and Process   Qualifications (IQ, OQ, PQ)
- Manufacturing Flowcharts
- Supplier Relations    (International and Domestic)
- Configuration Management
- Manufacturing and Inspection equipment development and qualifications
 

- Design Controls
- Quality Plan Development
- Design Verification &    Validation Requirements
- FMEA Risk Analysis/    Mitigation (Application,    Design, and Process)
- IEC 60601 Medical Device
  
Safety Standards
- Six Sigma Green Belt  Trained

 PROFESSIONAL EXPERIENCE

AtriCure Inc (Previously ENABLE Medical),
West Chester, Ohio
Sustaining Engineering Project Leader


2005 - Present

-         Responsible for leading engineering efforts for developing, analyzing, executing and supporting new product development and design changes. Responsibilities range from creating Quality Plans, CAD Design, Protocol and test plans, Inspection strategies, Design Verification/Validation and process development.

   o  Position Highlights

§  Release new product codes for extending company’s product catalog to meet market needs.

§  Identify and qualify material or component replacements due to supply chain disruptions.

§  Provide technical assistance to customers and field associates’ inquiries.

§  Confer with Surgeons to review therapeutic impacts of design changes and risk mitigation.

§  Provide technical support for Regulatory Engineering to obtain submissions in new International markets.

§  Directed company Biomedical Engineering cooperative education program with University of Cincinnati.

§  Led the planning and implementation of FDA mandate for Unique Device Identification (UDI) for Class III and Class II Implant products.

§  Identified and implemented companywide initiatives such Quality System upgrades to accommodate business dynamics due to substantial business growth.  

§  Identify opportunities to improve manufacturing capacity and cost savings of existing products, such as product redesign from arduous assembly to insert-molded device, saving many hours of labor and scrap and to promote improved product performance repeatability.


Contract Design Assignments,
Greater Cincinnati, Ohio area
Engineering Design Consultant


2003 - 2005

  •  Developed creative solutions for automotive industry component logistic trays (transport, storage, and process) and generated injection molding bases and cores utilizing SolidWorks.
  • Collaborated with Proctor and Gamble researcher, marketing and industrial design team for development of electronic consumer cleaning device by generating 3D computer models to produce SLA models for marketing review.
  • Developed automated packaging production equipment for Proctor and Gamble feminine hygiene products division.
  • Designed electronics packaging for a high power digital television transmitter for Harris Corporation in Mason Ohio.

E-Prime, LLC,
Cincinnati, Ohio
Principal Designer


2001 - 2003

  • Provide design solutions to Surgeons and develop their Intellectual Property for new devices to be used for innovative surgical techniques.  Taking their concepts from a feasibility stage to market-launch preparedness.  New product concepts have included endoscopic and orthopedic devices.
  • Developed new tendon repair device by working closely with industrial designer and creating 3-D database models that were used by mold makers to create components.  Using SolidWorks 2001, I created IGES and SLA files that were used to develop rapid prototype parts to prove concept feasibility.  The product was developed in 4 months and ready for market within 6 months.
INNOVATA INC., Fairfield, Ohio
Sr. Designer

1999 - 2001

  • Redesigned luxury boat refrigerator to lower manufacturing costs and incorporate the latest production and assembly processes. This resulted in a lower cost unit with enhanced features and increased performance. 
  • Led design efforts of automated part inspection station by creating 3-D layouts using Pro/E software to demonstrate machine’s features and functionality to the customer.  Initiated and completed detailed design efforts for delivery to production shop for build.
ENABLE MEDICAL CORPORATION, West Chester, Ohio
Designer

1996 - 1999

  • Contributed to the development of transferring RF energy through surgical scissor, allowing surgeons to cauterize blood vessels while cutting tissue. 
  •  Provided design and engineering support, patent research, lab product testing, prototype development, 3-D iges files for rapid prototyping parts, mechanical components testing, and materials research.
  • Developed and implemented documentation control system, standards, and part numbering system to satisfy FDA and ISO9001 requirements.
BELCAN ENGINEERING SERVICES, Cincinnati, Ohio
Designer (D2) (Assigned to BGP Services)

1993 - 1996

  • Developed Encapsulation conveyor for Proctor and Gamble International diaper lines; specifically Japanese converters.
  • Performed supplier inspections and provided construction field support for fabrication and installation of Splicer delivery system.
  • Acted as Lead Designer giving other designer and detailers direction for project completion.
  • Actively involved in selection of conveyor’s commercial parts, such as gears, linear actuators, and other mechanical components and drives.

Designer  (Assigned to Liebel Flarsheim)

  • Completed Assembly drawings of Hydradjust Urology Table for market release.
  • Assisted Systems Manager in conversion of Apple environment to PC Novell network.
  • Designed accessories for aforementioned surgery table
ETHICON ENDO-SURGERY, Cincinnati, Ohio
Designer, Product Development  

1991 - 1993

  • Designed and detailed, from concept, market dominating Endo-Scopic hernia instrument.
  • Implemented, directed, and instructed CAD training courses for manufacturing employees which saved the company thousands of dollars in the hiring and training of entry level design/drafters. Also promoted in-house advancement.
  • Developed proficiency in creating 3-D wire frame, NURB surfaces, and Solid models of plastic components.
CAMPBELL HAUSFELD, Harrison, Ohio
Layout Draftsman

1988 - 1991

  • Created layouts, stack-ups, and details of consumer air compressors.
  • Initiated prototype development of new product designs.
  • Completed advanced applications of ANSI Y14.5M - 1982 course given by Technical Consultants Inc.
  • Attended and completed Boothroyd-Dewhurst Design for Assembly (DFA) training seminars.
 EDUCATION
Xavier University - Xavier Leadership Center, Cincinnati, Ohio
Project Management Certificate Program

University of Cincinnati
- College of Applied Science, Cincinnati, Ohio
Continued education towards my Bachelor's of Applied Science in Mechanical Engineering Technology. (evening courses)

Cincinnati Technical College, Cincinnati, Ohio
Associates of Applied Science- Mechanical Engineering Technology.


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