STEVEN L HENDERSON, CPM
Product Design / Sustaining Engineer
Loveland, Ohio
contact: steve@shender4.com

Accountable Leadership. Value-Based Optimization through Design Effectiveness

Semi-retired project engineering professional with creative, resourceful and organizational skill sets in Research & Development, 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:

2017 - 2022

• Led Research and Development efforts to generate new technologies and product platforms to enhance company's product catalog and IP portfolio.
• Established and executed Feasibility agreements with Pharmaceutical partners to evaluate unique configurations of Enable's devices to determine performance characteristics and compatibility with partners' drug products and/or mimic solutions.
• Directed and managed priorities for team of 12 R&D staff members, including Engineers, Industrial Designers, Lab Technicians and consultants (internal and external) assuring department's activities were aligned with corporate objectives.
• Supported Business Development and Program Management departments' activities to promote concept models and designs to external customers to advance products towards commercialization.

2005 - 2017

• 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.

Position Highlights:

• Released new product codes for extending company’s product catalog to meet market needs.

• Identified and qualified material or component replacements due to supply chain disruptions.

• Provided technical assistance to customers and field associates’ inquiries.

• Conferred with Surgeons to review therapeutic impacts of design changes and risk mitigation.

• Provided 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.  

• Identified 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. 

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 Procter and Gamble researchers, 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 product production equipment for Procter and Gamble feminine hygiene products division.
• Designed electronics packaging for a high power digital television transmitter for Harris Corporation in Mason Ohio.

2001 - 2003

• Provided 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.

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.

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.

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

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.

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 GD&T course given by Technical Consultants Inc.
• Completed Boothroyd-Dewhurst Design for Assembly (DFA) training seminars.

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

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