Engineer Medical Device

Joel L. Apley

**** ******* ****, *********, ** **921 • 865-***-**** • ****.*****@*******.***

Summary

Solutions for computer networking, mainframe, and client/server applications associated with various industrial and commercial enterprises. Extensive knowledge of industry related standards, codes, and guidelines with ability to apply knowledge into practical applications, with extremely strong troubleshooting skills.

Extensive knowledge of regulated environment requirements, including FDA, German Health Authority (GHA), and Clinical Laboratory Improvement Amendments (CLIA).

Highlights

Saved over $400,000 through reconfiguration of vendor storage requirements.

Designed the first 510K medical device submitted for certification in the history of CSL Plasma.

Streamlined hotel automation processes, resulting in improved efficiency of internal functions, increased customer satisfaction, and overall improved ratings.

Redesign networking for CSL Plasma testing instruments to reduce overall network load

Professional History

Systems Engineer II, CSL Plasma, 1001 Corridor Park Blvd, Knoxville, TN 37931

Infrastructure Project Lead on all FDA-regulated projects associated with plasma testing and shipping.

Served as the single point of contact for Project Managers, Infrastructure Managers, Quality Control, and IT Director, to ensure regulated systems were maintained and kept in compliance with FDA and GHA regulations.

Designed, configured and documented Microsoft Clustered Server based FDA regulated network system used for training, validation of application software, and procedure validation for Plasma Testing Laboratory, resulting in 99.7% system availability.

Designed, documented and installed FDA regulated electronic packing slip system for non-networked Plasma Centers owned by the company. This design is being submitted to the FDA to be the first 510K medical device submitted for certification in the history of the company.

Trained department employees in an FDA-regulated environment on procedures and regulations

Performed final IT review on all Installation Qualifications and procedures executed on FDA regulated systems.

Accomplished daily administrative tasks on Microsoft Windows servers network utilizing the Microsoft Cluster Server service to provide high availability and fully redundant networked systems for 24/7 FDA Regulated Plasma Testing Laboratory.

Created, authored and tested System Architecture Documents, Infrastructure Installation Qualifications, Verification Test documents, procedures and policies in compliance with the company's System Life Cycle Procedures

Saved over $400,000 through reconfiguration of vendor storage requirements. Created system solutions for specific projects, company-wide rollouts and network expansions.

Provided 3rd level support to Help Desk and IT Personnel, providing 24/7 support in company operations critical systems.

Deployed Windows Virtual servers globally on a wide variety of global projects.

Standard system administration when required.

5/2001 – 8/2018

Senior Interface Analyst – Hotel Systems Division, GEAC Computers, Tustin, CA 92680

Interfaced Unix based hotel hospitality systems to a wide variety of hotel automation equipment (PBX phone switches, Call Accounting Systems, video systems, point of sale, and energy management).

Trapped individual data streams from vendor equipment; analyzed and made changes to data streams, then configured dedicated server hardware and software to accept and properly interpret data to allow full automation of hotel.

Provided second level, 24/7 support of all interface-related issues covering a worldwide geographical area

Worked directly with software development testing and debugging software packages, analyzing software performance and making suggestions for modifications and alternate applications.

Provided training and support for other Interface Analysts.

Position required working with no supervision and extensive travel.

1/1997 – 1/2001

Senior Field Engineer; Network Technology Services, GEAC Computers, Troy, MI

Installed, troubleshot, preventative and corrective maintenance on UNIX based library, financial, and hotel information/automation systems.

Installed cabling, network equipment, hardware and software of proprietary systems.

Providing training and 24/7 technical support for other field engineers.

Inventory control, shipping and receiving and various administrative duties.

1/1986 – 1/1997

Education

Tennessee Institute of Electronics - Knoxville, TN 37917

Received both a Specialist Degree and a Specialized Associates Degree in Electronics Technology.

Roane State Community College - Oak Ridge, TN 37830

Certified Electronics Technician by the International Society of Certified Electronics Technicians.

Certified as a Novell 3.12 Network Administrator - Certification date: 03/09/95.

Microsoft Certified Professional

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