*Gilbert E. Bandry

Senior Systems Engineer/Human Factors & Usability Engineer (HF&UE)

Cell: 440-***-****

LinkedIn: https://www.linkedin.com/in/gilbert-e-bandry-75a3b729/

Email: ac7zfc@r.postjobfree.com

SUMMARY

Experienced professional with a demonstrated history of working in government regulated industries. Skilled in new product development (NPD), User Experience (UX)/User Interface (UI) design, Verification & Validation (V&V) studies and Risk Remediation with a Master of Science (M.S.) in Human Factors Engineering (HFE).

EXPERIENCE

Human Systems Integration Sr. Systems Engineer/Human Factors & Usability Engineer/Quality Engineer Consultant at Carlton National Resources

February 2018 – Present

Provided subject matter expertise in User Experience (UX)/User Interface (UI) design, Verification & Validation (V&V) studies and Risk Remediation in new product development (NPD) and Design History Files (DHFs) for medical devices including:

Sleep apnea devices

Oxygen Concentrators

Oxygen Conservers

Oxygen Concentrator

Design Verification & Validation (V&V) Engineer at Drive DeVilbiss Healthcare (Carlton National)

February 2018 – June 2018

Analyzed device requirements and developed Test Plans and Protocols to Verify/Validate requirements compliance for both sleep apnea and respirator devices

Executed Verification/Validation (V&V) Tests/Evaluations for sleep apnea devices

Prepared formal V&V Technical Reports for sleep apnea devices

Developed Design History Files (DHFs) for legacy respirator devices in support of Risk Remediation

Consultant (Usability Engineer (UE)/Risk Remediation) at Zimmer Biomet Surgical (GForce Life Sciences)

February 2017 – March 2017, November 2017 – March 2018

Reviewed post market data such as Non-conformances and complaints analysis and coordinating risk remediation activities with stakeholders and peers.

Analyzed results from Hazard Analyses, DFMEAs, Safety Test Reports and Validation Studies to ensure product design met ISO 14791, ISO 62366 and ISO 60601-1-6 requirements

Participated in the evaluation of risks related to product use with focus on both standard operating procedures and any currently existing risk management files

Generated usability engineering files and providing input into risk management files for Sixty-one (61) Class I/II legacy surgical product Design History Files (DHFs) supporting that use requirements were met and necessary risk controls were applied and effective

Principal HFE/UE at ZOLL Medical Corporation

June 2017 – July 2017

Responded to FDA inquiries pertaining to findings derived from structured product evaluations, usability assessments and Verification & Validation (V&V) studies of medical devices as part of the Pre-market Assessment (PMA) for an automated external defibrillator (Class III) medical public access device (PAD)

Principal Observer in HFE Summative Study to support design optimization and identify potential use errors of a mechanical ventilation (Class III) medical device

Senior Systems Engineer (HSI/HFE/ILS) at General Dynamics Land Systems

September 2004 – April 2016

Served as Human Systems Integration (HSI) liaison between Management, the User and USG for two large-scale System-level Major Defense Acquisition program (MADPs) development efforts

As HSI lead provided oversight over the following areas: User demographics, capabilities and organizational structure, training, System Safety Engineering (SSE), Health Hazards and Human Factors Engineering (HFE)

Through participation in a variety of matrix-structured cross-functional Integrated Product Teams (IPTs) ensured application of proper user-centered design and human engineering principles to product research, development, and design based on Standard Operating Procedures (SOPs), HFE guidelines, Military Specifications and DoD regulations and guidelines.

Contributed to Whole System Architecture (WSA) and Software Requirements Specifications (SRS) through collaboration Functional and Critical Task Analysis (CTA) of Primary Operating Functions, Use Cases, Trade Studies and User Interface (UI) Specifications

Per Customer defined Contract Deliverables Requirements List (CDRLs) provided periodic HFE Analysis, Workload Assessment and User Performance reports to both USG and senior management

Contributed to Risk Management of associated product use errors and safety considerations through collaboration of risk analysis and resolution using Root Cause Corrective Action (RCCA) techniques

Served as Senior Systems HFE Technical Lead on a variety of System-level/Subsystem-level product upgrade efforts

Translated customer requirements into key HFE-related System/Subsystem-level specifications

Developed Test Plans, questionnaires, metrics and test reports for both User verification and validation studies of new hardware/software User Interfaces (UIs) and their impact to performance

Served as configuration control liaison to United States Federal Government (USG) for new operating procedures for Integrated Logistics Support (ILS) activities

Contributed to continuous improvement initiatives in terms of standardizing company-wide procedures and identifying opportunities to integrate emergent technologies in new product development efforts

Performed periodic internal department audits and updated standard practices and procedures based on findings

Contributed to development of Bids and Proposals for New Business opportunities

Possessed a Secret-level security clearance

Personal Tutor (Collegiate & HS Sciences & Languages) at Independent

February 2004 – Present

Provide personal tutoring services and study packages in the following subject areas:

1.College and HS AP/Honors/General Pre-Algebra - Differential Equations

2.College and HS AP/Honors/General Physics

3.College and HS AP/Honors/General Chemistry

4. College and HS AP/Honors/General Spanish(I-IV)

5.College and HS AP/Honors/General English

6.SAT/ACT Math Prep

Consultant (HSI/HFE) at Human Systems Information Analysis Center (Booz Allen & Hamilton)

September 2000 – January 2003

Project manager for the development of training materials to facilitate use of the Defense Technical Information Center Management Information System in the contract approval process

Provided usability and human factors guidance into the network design of a large-scale system-level MDAP

Researched and identified emerging tools in user-centered designs, including the framework for Cognitive Task Analysis (Workload Assessment)

Possessed a Secret-level security clearance

EDUCATION

Wright State University

Masters of Science (M.S.), Human Factors Engineering (Occupational & Industrial Ergonomics), 1999 – 2001

Thesis: Open-Loop Posture Control Algorithm for Strength Enhancement Exoskeleton using Pneumatic Muscles

Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering, 1995 – 1999, GPA: 3.83

Senior Design: Frangible Knee Leg-form

Societies: Tau Beta Pi, Sigma Phi Epsilon

SKILLS

Proficient in Spanish

Subject Matter Expert in:

Department of Defense (DoD) Standards and Specifications (MIL-STDs/HDBKs)

Medical Device industry (AAMI/ANSI/IEC/ISO) Standards and Specifications

Code of Federal Regulations (CFR),

International (ISO/SAE) Standards and Specifications

Proficiency with

Whole Microsoft (MS) Office suite

Product software modeling toolkits:

oVis Mockup

oPro-E

oSiemens JACK Virtual Manikin Physical Accommodation

oImproved Performance Research Integration Tool (MPRINT) Workload

PUBLICATIONS

The Department of Defense and Human Factors Engineering: Changing with the Times (HSIAC Gateway Vol. XIII: Number 2, 2002)

WEB PREMIS User-Oriented Training Manual, revision 3.1 (HSIAC-TR-2002-026)

Performance Results Management Information System (PREMIS): Advance training technology development (HSIAC-TR-2002-023)

Human Performance Data as it applies to Military Operations in Urban Terrain, Vol. 1: Non-copyrighted Literature Search Results (HSIAC-SS-2002-003)

Human Performance Data as it applies to Military Operations in Urban Terrain, Vol. II: Copyrighted Literature Search Results ( HSIAC-SS-2002-003)

Posture Control Algorithm Strategy for Enhanced Human Performance Exoskeletons

A Tool for Synthesis of Biodynamic Motion

Performance Results Evaluation Management Information System (PREMIS): Usability Test & Evaluation (HSIAC-TR-2001-012))

Biomimicry & Optimal Design of Pneumatic Muscle Actuators Using MEMS

EXTRACURRICULAR ACTIVITIES

Great Ohio Bicycle Association (GOBA)

Western Reserve Rowing Association (WRRA)

Big Brothers/Big Sisters of America

Family Faith Church/Genesis Church Bible Study

Genesis Church Soup Kitchen volunteer

Lake Farmparks children activities volunteer

Holden Arboretum Horticulture

Cleveland Botanical Gardens Security

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