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, addressed failures, customer complaints, issue tracking, and repair and service program.• 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.• Implemented new Alpha II product line of sound processor reducing inventory from 16 unique products to 4 unique products that fulfilled all requirements of previous 16.• Transformed processor assemblies from in-house painted LCP to color injection molded from custom compounded ABS materials including product and mold improvement specification. • Worked extensively with Marketing Director and CEO to meet new product demands, keep up with business expansion, marketplace needs, and sales trends including restructuring manufacturing process to produce DEMO devices for growing sales team.• Created new Alpha II customer device storage case including developing engraving process, procedures, equipment specification, and designing necessary fixtures for implementation of company logo laser marking on case, magnetic baseplates, and permanent serial number ID.

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 closely with European Surgeons to develop surgical techniques and procedures. • Implemented engineering changes in surgical procedures that reduced surgical implant procedure time.• Specified and procured $750K in manufacturing equipment including electro-plating, metallurgical inspection, and inspection labs, video CMM machine, and modeling machine shop.

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 vascular graft for medical products division, Interventional Technologies Division.• 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.• Supervise electronics staff incl. 9 electrical engineers, 5 machinists, and clean room personnel. • Oversee electrical control systems for over 50 in-house built manufacturing machines, facilitating equipment builds to comply with NEC and GMP-ISO requirements.• Organized electrical layout and specifications of 5K sq. ft. clean room in Nogales, Mexico.