Misty L. Pyatt
Golden, CO 80401 • (760) 445-1190 • mistycoburn@gmail.com • LinkedIn Profile
SUMMARY
Quality professional with extensive experience working for global and start-up medical device and
pharmaceutical companies in FDA regulated environments. Expertise in quality compliance (ISO 13485), design
controls (FDA 21 CFR), cGMP, auditing, equipment controls (GAMP), process/product development, and
manufacturing. Proven abilities in program management, quality system (QMS) improvements, regulatory
compliance remediation, change control, problem solving, and technical writing.
PROFESSIONAL EXPERIENCE
AMGEN, Longmont, CO
Senior Quality Engineer
2013 – Present
Lead and support FDA warning letter remediation activities to deliver on key regulatory and organization
commitments, including alignment of currently marketed combination products with FDA regulations (21 CFR),
industry standards (ISO) and organization quality management system (QMS).
 Manage Corrective and Preventive Action (CAPA), Nonconformance (NC) and Change Control records as
lead Quality contact.
 Review and approve deliverables associated with retrospective assembly of combination product design
history files (DHF), patient Information for Use (IFU) updates and design validation, design verification
testing and GMP documentation improvements.
 Represent Device Quality organization on CAPA system improvement project teams.
 Support development of mechanical and electro-mechanical combination products throughout all
design control phases as Core Team member or as Independent Reviewer during design reviews.
COVIDIEN (formerly ev3 Neurovascular), Irvine, CA
Senior Technical Writer (Principal Quality Engineer)
2011 – 2013
Lead efforts to create and/or update organization quality management system (QMS) procedures and
subsystems associated with the product development process (PDP), design controls and change controls.
 Drive consistency in content and format of PDP deliverables across multiple project types through a
Lean value approach, while ensuring compliance with global regulations and harmonized standard
requirements.
 Lead and support development and execution of training modules, presentations and other materials to
train and develop all departments of the organization on new and revised PDP elements.
 Author and manage updates to organizational policies, Design Controls procedures and ancillary
procedures or guidance documents to improve alignment with regulations, global organization
procedures and divisional requirements.
 Mentor new product development and commercial product teams, including management, engineering
and Document Control, on QMS improvements to ensure project goals are met.
COVIDIEN (formerly ev3 Neurovascular), Irvine, CA
Senior Development Engineer
2011 – 2012
Managed process development engineering team and related design control activities associated with
development and design transfer of a breakthrough neurovascular access catheter and clot retrieval system.
 Develop and optimize design of access catheter, stent system and processes to meet product
specifications and manufacturing requirements. Activities include equipment procurement, process
characterization, test method development and validation, and fixture/tooling/manufacturing aid
development and validation.
Misty L. Pyatt • (760) 445-1190 • mistycoburn@gmail.com
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 Manage development builds in pilot lab and production settings, including training operators,
coordination with production planning, preparation of work orders, materials management, and device
master records (DMR) for manufacturing.
 Author, approve and execute risk assessments, test method qualification protocols/reports, equipment
qualification plans/protocols/reports, IQ/OQ/PQ protocols/reports, build protocols/reports, and
notebook studies.
 Present process development activities and results to management and product transfer team
throughout various phases of product development process.
EDWARDS LIFESCIENCES, Irvine, CA
Staff Manufacturing Engineer
2010 – 2011
Developed and implemented lean manufacturing principles into production for commercially released product.
 Communicate program progress, needs and successes to upper management and multiple departments
throughout the organization.
 Analyze data by properly identifying and coding product and operator flow. Provide solutions to
implement lean manufacturing.
 Identify and coordinate with suppliers to develop custom equipment, tools and manufacturing aids to
successfully meet lean manufacturing needs.
 Train, develop and mentor team members (both direct and indirect reports).
MEDVENTURE TECHNOLOGY, Jeffersonville, IN
Process Engineer
2008 – 2010
Lead process development engineering team to develop product, processes and equipment for next generation
hemostatic clipping device and stent delivery systems.
 Coordinate with clients and suppliers to outline risks, user needs, project schedules, capacity models,
production line layouts, equipment/fixture/tooling designs, validation requirements and design transfer
strategy.
 Identify and coordinate with suppliers to develop custom equipment, tools and manufacturing aids to
meet automated manufacturing needs.
 Project leader, Process Engineer and Equipment Design Engineer for laser welding of small scale
components with automation and vision control.
 Provide guidance and author updates to internal Design Controls procedures and ancillary procedures or
guidance documents to improve alignment with client needs and global regulations.
 Technical advisor on stent delivery system program, providing guidance on test method development,
balloon supplier selection and process development.
ABBOTT VASCULAR (formerly Guidant Corporation), Temecula, CA
Senior R&D Engineer
2005 – 2008
Repeatedly recognized for top performance through promotions of increasing responsibility and selection for
high-priority initiatives.
 Balloon Technology Engineer, leading research and development of polymer materials, processes and
equipment for breakthrough dilatation and stent delivery systems.
 Project Lead and Equipment Design Engineer for next generation stent retention and hydrophilic coating
equipment.
 Equipment Validation Engineer for next generation drug spray coaters for drug eluting stent programs.
 Equipment Controls Representative for Drug Eluting Stents (DES) business unit to ensure compliance
with organization’s new equipment lifecycle procedures, associated subsystems and global regulations.
Misty L. Pyatt • (760) 445-1190 • mistycoburn@gmail.com
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OTHER PROFESSIONAL EXPERIENCE
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Design Engineer, Breg, Inc., Vista, CA (2005-2005)
R&D/Mechanical Engineer, Guidant Corporation, Temecula, CA (2001-2003)
Manufacturing Engineer, Guidant Corporation, Temecula, CA (1998-2001)
Translating Voice of Customer (VOC) and global regulations into effective policies, procedures and
guidance documents.
 Proficiency in technical writing throughout various industries (medical device, pharmaceutical, therapy
delivery), across multiple areas of expertise (quality compliance, quality engineering, process
development, equipment development, manufacturing) and within organizations of varying sizes.
 Detail oriented, methodical and organized, results driven.
EDUCATION
Colorado School of Mines, Golden, CO
Bachelor of Science, Chemical and Petroleum Refining Engineering
1993 – 1997
TECHNICAL SKILLS
 Knowledge and use of software applications, including Microsoft Office (Word, Excel, Project,
Powerpoint and Visio) and statistical applications (Design Expert, JMP, Minitab)
 Working knowledge of global regulations, guidances and standards (FDA 21 CFR, ISO 13485, ISO 14791,
GAMP 4/5, CE Marking)