Bill Simms Email & Phone Number

Monument CO

Contract position for Remendiation Project.Special Processes Supplier Validation remediation work.Critical review of supplier special processes evaluation of current practices ( validations ).

Boulder, Colorado

• Oversaw product design, manufacturing processes, FDA compliance, production operators, shipping and receiving, and daily operations. Managed and developed Quality Engineering improvements of existing product lines.
• Led company from $150K sales with one product line to multiple product lines and sales growth nearing $5M in only two years, achieving manufacturing yields on all product lines of > 95%.
• Developed and implemented key manufacturing changes and programs to increase productivity by applying CNC technology, converting hand built molded assemblies to machined parts.
• Increased manufacturing capacity from 10-12 devices per week to 60+ per week.
• Saved $185K/year in operating costs by developing second source vendor for magnetic titanium implant including managing all project and design controls.
• Developed, validated sterile packaging for new implant, receiving FDA and EU approvals for use.

Boulder, CO

• Senior Project Manager and Mechanical Engineer for development of bi-polar fully implantable connector for middle ear implant and Cochlear Implant requirements.
• Developed in house manufacturing, operational, and maintenance procedures, specifications docs, ECOs, machine validation, equipment IQ, OQ, and PQ processes in accordance with ISO 9000, GMP, and CE reqs.
• Established new product design and manufacturing system for implantable hearing aid device.
• Project Engineer for $500K Hermetic NdYag Laser Welding Machine including developing and validating weld fixture processes and procedures for producing hermetically sealed and welded devices.
• Managed design controls, manufacturing testing, and surgical procedures for new product line as Lead Project Manager for Met-V Project (Transducer for Conductive and Mixed Loss, Atresia Applications) including working.
• Implemented engineering changes in surgical procedures that reduced surgical implant procedure time.

Flagstaff, Arizona Area

• Developed technology and machinery for manufacturing of Endoprosthesis, Thoracic, and Vascular Nitinol Stents and manufacturing processes for building Axilo-Bifemoral Bypass Ringed Graft and tapered Aortic ePTFE.
• Reduced manufacturing time from 75 min/unit to 10 min/unit by developing 4-Axis CNC machine to automatically wind bifurcated stents that eliminated ergonomic risks of manual stent winding.
• Project manager for $350K 4-Axis CNC vision system guided Co2 laser cutting machine that reduced materials costs by $12/unit, increased yields from 80% to 98%, and decreased hand motion risks.
• Designed and implemented Co2 laser manufacturing process for new ePTFE AV Access Graft material.
• Lead Mechanical Engineer incl. design and validation of all manufacturing equipment for Graft project.
• Wrote specifications and negotiated $125K contract to purchase CNC Laser cutting machine.