Medical Device Engineer

Preston Kelly, CMDCP, EIT

**** ******** *****, *********, ** 37922

*********@*****.*** www.linkedin.com/in/prestonkellybiomedicalengineer

Cell: 865-***-****

Preston Kelly is a Biomedical Engineer and certified Engineer in Training with experience in the fields of pharma/medical device C&Q/V&V, quality assurance, maintenance, microfabrication, and orthopedic implants. He has led test execution, validation engineering, and medical device design and manufacturing projects involving a wide variety of systems and equipment while working for the past five years in a FDA/ISO regulated industry. In addition, he has gained extensive hands-on knowledge of aseptic filling isolator equipment lines and processes for both vial and syringe filling operations. He is very detail-oriented, yet adaptive, with strong communication and computer skills. He is a Certified Medical Device Compliance Professional (CMDCP) through CfPIE and is working towards becoming a Certified Biomedical Auditor (CBA) through ASQ.

WORK HISTORY

Commissioning Agents, Inc.(CAI)

Validation Engineer (09/2009 - 08/2014):

• Contracted to projects for pharmaceutical and medical device manufacturers to ensure compliance with FDA/ISO regulations through quality assurance, protocol development, and engineering test execution.

Center for Musculoskeletal Research

Graduate Research Assistant (07/2007 - 06/2008):

• Conducted research at Oak Ridge Nanoscience Technology Laboratory

• Gave project presentations and written updates

• Responsible for cleanroom laboratory equipment repair and upkeep

• Worked in conjunction with other graduate students on research funded by Zimmer Orthopedics® in order to improve Gender Solutions™ knee implant

EDUCATION & TRAINING

Education: • B.S., Biomedical Engineering; Minor in Materials Science Engineering, University of TN (2002-2007)

• M.S., Biomedical Engineering with a concentration in Musculoskeletal Biomechanics, University of TN (2007-2009)

Certifications: • Certified Medical Device Compliance Professional (CMDCP)

• Registered Engineer in Training (EIT), Tennessee

KEY COMPETENCIES

Medical Device V & V Quality Assurance Medical Device Regulations Orthopedic Implants Commissioning and Qualification Risk Assessment/FMEA Pharmaceutical Manufacturing FDA Regulatory Compliance Aseptic Filling Isolators Temperature Mapping Laboratory Instrumentation Process Validation

Summary Report Development Data Collection and Processing Periodic Quality Evaluations Medical Device Design Control

SPECIFIC PROJECT EXPERIENCE

Meridian Medical Technologies (Pfizer)

St. Louis, MO

• Wrote Equipment Specification Document for EpiPen manufacturing line.

• Co-authored and evaluated SOPs for the overhaul of the QA Validation department.

• Wrote and executed technical QA documents for the qualification of combination medical devices for Department of Defense.

• Team member of a large effort to bring the company back in compliance with FDA regulations after

being cited with multiple 483 observations.

Terumo Cardiovascular Systems

Ann Arbor, MI

• Authored and evaluated FMEAs for medical devices and their associated chemistries used in openheart surgery.

• Led the sweep and scrub of manufacturing work instruction protocol for assembly and testing of medical devices.

• Authored and executed EQs, IQs, OQs, and PQs for both surgeon products and cardiovascular

devices, along with their associated summary reports.

Cook Pharmica

Bloomington, IN

• Led commissioning, IQ, OQ, and PQ execution activities on contract manufacturing syringe and vial filler line and their associated barrier isolators.

• Helped in execution of client process validation (PV) batches in the Small Scale Form/Fill/Finish

(SSFFF) area.

• Responsible for collecting PV samples, ensuring completion of documentation, and communicating with the Validation team.

• Participated in the collection of data for clients’ PV summary reports by reviewing applicable batch

records and PV protocols to assist with drafting the reports.

• Responsible for drafting media fill summary reports.

Eli Lilly • Assisted in Periodic Quality Evaluations (PQEs) and reevaluation of Component Criticality

Indianapolis, IN Assessments (CCAs). Also participated in spare parts remediation and implementation project.

• Led commissioning, IQ, OQ, and PQ execution activities on syringe and vial filler line and their

associated barrier isolators. Worked on every system on vial line from vial washer to tray counter.

Oak Ridge National Laboratory

Oak Ridge, TN

• Nanoscale Science and Technology Laboratory engineer charged with the task of maintaining and repairing nanofabrication equipment.

• Researched and designed novel guided shear horizontal surface acoustic wave sensor for early

detection of infection precursor molecules following total knee arthroplasty. This work included extensive study of FDA 21CFR820 for regulatory purposes.

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