Engineer Manufacturing
Resume:
William J. Simms
*** * ****** **. **********, CO 80027
*******@***.***
A highly technical individual with over 30 years experience in Class 3 Medical Products Manufacturing.
Demonstrated success in product development and manufacturing improvements for related product technology
development and applications. Extensive Senior Engineer background, with proven contributions in these areas.
Machine design, New product design and development, Machine validations, Manufacturing support, Machine
shop operations, Industrial electrical systems, Electronic machine controls and Electronics.
Proven team leader and mentor for Manufacturing Engineers, as well as a background including skill
sets as a certified trainer for Clinical Surgical Procedures for Otologics surgical support personnel. Certified
trainer for United States and European Clinical Trial participating Surgeons.
Summary of Qualifications
• Mechanically minded individual with the ability to apply knowledge to find cost effective solutions to
medical manufacturing operations.
• Strong verbal, written, and interpersonal skills.
• Strong understanding of manufacturing machinery and systems.
• Proven experience in the design and implementation of CO2, Nd Yag laser systems and ergonomic
manufacturing equipment.
• Solid Works, ProEngineer, Cadkey, AutoCad, MasterCam, CuttingEdge, and Rapid Prototyping.
• Thorough understanding of machine tool and laser controls, Centroid, Fanuc OM, Prolite 2000, Acorad
CNC 2000, and MaxNC.
• Strong machine shop experience.
• Experience with TIG, MIG, SMAW, and GAS welding and Laser Hermetic Welding of Titanium and
Stainless Steels.
• Proven abilities in key contract negotiations, capital equipment procurement, and key vendor relations.
• Cross functional experience working with Management, Quality Control, Manufacturing, Manufacturing
Engineering, Product Specialists, Clinicians, Surgeons and OR personnel.
• Professional Training: Temporal Bone Training at House Ear Institute, Vanderbilt University and
University of Colorado, Laser Safety Officer.
Experience and Accomplishments
OTOLOGICS, LLC Boulder, CO 1999 to present
Middle Ear Ossicular Stimulator Manufacturer Start-Up Class 3 Medical Manufacturer
Sr. Manager Training / Surgical Trainer 2005 to present
• Project Manager Met-V Project, Transducer for conductive and Mixed Loss, Atresia Applications.
Managed Design Controls, manufacturing, testing, Surgical procedures for new product line. Worked
with European Surgeons to develop Surgical Technique and Procedures.
• Execute training objectives for programs and implementation of Otologics Surgical / Product
Training.
• Trained Otologics Field Support Personnel in US and Europe for Clinical Trials.
• Trained Otologics Surgical Personnel in US and Europe on Temporal Bone Implantation of Otologics
Device.
• Trained US and European Surgeons on Temporal Bone Implantation of Otologics Device.
• Provided Technical Support during Surgeries in US and Europe for Clinical Trials of Fully Implantable
Device.
• Provided Engineering and Technical Surgical Support for Conductive Loss / Mixed Loss and Atresia
applications of Otologics Fully Implantable device during Clinical Trials in Europe.
• Implemented Engineering changes in the Surgical Procedure to reduce Surgical Time required to
complete the Implant Surgical Procedure.
Sr. Manufacturing Engineer 1999 to 2005
• Following Internal Design Controls implemented the following projects and tasks:
• Responsible for establishing manufacturing system for implantable hearing aid device.
• Facilitated 10,000 sq. ft. manufacturing facility for business needs.
• Specified and procured $750K in manufacturing equipment, Electro-plating lab, Metallurgical
inspection lab, Inspection Lab, Video CMM machine, set-up Modeling Machine Shop.
• Project Engineer for $500K Hermetic Laser Welding Machine. Wrote machine specifications,
negotiated purchase contract, designed tooling and welding fixtures for 4 Axis CNC Laser Welder.
• Developed processes and procedures for producing hermetic sealed and welded devices.
• Wrote specifications documents, ECO’s, machine validation, maintenance procedures and operational
procedures in accordance with GMP and FDA 21 CFR Part 820, and CE requirements.
• Project engineer for 1,000 sq. ft. Class 10,000 Clean Room construction project. Responsible for
facilitation, room layout, contractor management, and room qualification of new clean room for
manufacturing.
• Specified, procured and managed installation of Packaging Clean room and packaging equipment.
W. L. GORE & ASSOCIATES INC. Flagstaff, AZ 1977 to 1999
MEDICAL PRODUCTS DIVISION
Manufacturing / Product Development Engineer 1990 to 1999
Interventional Technologies & Vascular Graft Division
• Developed technology and machinery necessary for the manufacturing of Endoprosthesis, Thoracic, and
Vascular Nitinol Stents, along with manufacturing processes for building an Axilo-Bifemoral Bypass
Ringed Graft and the only tapered Aortic ePTFE vascular graft.
• Project Engineer developer of 4-Axis CNC machine to automatically wind bifurcated Nitinol Stents.
Machine eliminated the ergonomic risks of stent winding and resulted in a reduction of manufacturing time
from 75 min/unit to 10 min/unit.
• Project champion of a $350K 4-Axis CNC vision system guided laser cutting machine. System resulted in a
cost reduction of $12 per unit in materials consumed, an increase in overall yields from 80% to 98%, and a
decrease in ergonomic hand motion risks.
• Designed all tooling for laser cutting of stent grafts.
• Facilitated the purchase and implementation of CNC Machine tools and CAM software for building of
complex tooling for stent manufacturing.
• Designed and implemented laser manufacturing process for new ePTFE AV Access Graft material.
• Mechanical Engineer for Axillio-Bifemoral Bypass ePTFE Ringed Graft project.
• Designed and validated all manufacturing equipment for Axilo-Bifemoral graft project.
• Wrote specifications and negotiated contract to purchase CNC Laser cutting machine, $125k.
Electronic Department Supervisor / Manufacturing Engineer 1980 to 1990
Cardio-Vascular Suture Division, Ligament Project
• Supervisor of 9 Electrical Engineers / Electronic Technicians.
• Supervised Clean Room Maintenance personnel, 5 Machinists.
• Responsible for electrical control systems for over 50 in house built manufacturing machines.
• Facilitated the building of equipment to comply with NEC and GMP-ISO 9001 requirements.
• Facilitated the electrical layout and specifications of 5K sq. ft. clean room in Nogales, Mexico.
• Coordinated business needs between manufacturing leadership and shop personnel.
Electronic Dept. Technician / Manager 1977 to 1980
Electronic Products Division
• Installed, maintained and calibrated all manufacturing equipment.
• Designed and constructed new Electrical / Electronic control systems for a variety of manufacturing
equipment.
• Installed and maintained facility electrical 3 208V/480V systems, emergency lighting, PA system, and fire
control system.
COFFELT MANUFACTURING INC. Flagstaff, AZ 1990-1999 (part-time consulting)
Engineering Consultant, Electronic Technician
• Designed, built, and repaired full product line of portable electroshock equipment and boats utilized by the
Fish and Game Departments, many universities, and biological fisheries for anesthetizing fish.
• Designed and documented new market segment systems for electro-anesthesia units for west coast salmon
hatchery installations.
• Repaired, calibrated, and modified units as per service requirements and customer needs.
Education
B.A. in Education, 1975, Northern Arizona University, Applied Science, Minor in Electricity / Electronics
Patents
1. Adjustable Bone Bracket, US Patent 7326171, Issued: February 5, 2008
2. Compressive Coupling of an Implantable Hearing Aid Actuator to a Auditory Component,
US Patent 455**-*****, FCA, 6/14/2007, 11/763,257, PENDING
3. Asymmetrical Porous PTFE Form and Method of Making, Kasic, James F, Simms, William J, inventor.
W.L. Gore & Associates, assignee.
4. Improved Shunt Graft and Junction for Same, Lester Butters, Ramona Hicks, Brian Conn, William J.
Simms, Mike Hicks, inventors. W.L. Gore & Associates, assignee.
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