Richard B. Bordenkircher

**** *. ******* ******, ********, ID 83642

208-***-**** (Home) or 805-***-**** (Cell)

accm7j@r.postjobfree.com or accm7j@r.postjobfree.com

Multidisciplinary Biomedical Systems Engineer with

over 15 years experience developing innovative medical products/instrumentation,

comprehensive knowledge of instrument systems, systems integration, clinical applications, medical

sciences, and the product development process,

familiarity with Quality System Regulations, national and international regulatory standards, and

ability to develop rapport with personnel in various disciplines and levels,

integrates engineering and scientific disciplines into a total engineering effort to optimize total system

performance and engages in all phases of product development from conception through commercialization.

PROFESSIONAL EXPERIENCE

Oct 2010 – Present Project Engineer, Zona Health, Inc., Boise, ID

In a small company designing and manufacturing isometric therapy devices to alleviate hypertension:

Guide product development through Design Control process;

Research, organize, and prepare Design History File documentation including product and software

requirements and specifications, risk management, verification and validation testing, and reports;

Manage project deliverables from Marketing, R&D, QA, Regulatory, Manufacturing, and Customer Service

for product realization;

Upgrade the Quality Management System by expanding and/or creating the Quality Manual and Standard

Operating Procedures for product realization, design control, risk management, usability engineering, post-

market surveillance, documentation procedures, and CAPA;

Ensure compliance with FDA Quality System Regulations, international standards (e.g. ISO 13485 and

14971), and regional regulations.

2005 - 2010 Product Development Consultant, DataDancer Medical Systems, Chico, CA

In a start-up venture, developed “Hypertension Management Software” programs to record and assess patient

data from personal blood pressure monitors; wrote and/or assisted in documentation and validation. Three

Excel workbooks (Class II) cleared by FDA.

1993 - 2005 Senior Systems Engineer, Abbott Laboratories, Diagnostics Division, Santa Clara, CA

In the Hematology Business Unit, which develops blood analyzers using impedance technology and/or flow

cytometry:

Coordinated product development with cross-functional groups within R&D, with other departments within

the Business Unit, and with those outside the Business Unit

o Integrated instrument subsystems (hardware, software, and reagent) with hematology in method

development and testing, including identifying and mitigating risk;

o Served as lead technical consultant for R&D to other departments including Quality Assurance,

Regulatory, Marketing, Customer Service, Technical Product Development (reagents, calibrators, and

controls), and to Systems Verification/Validation group in developing methods and protocols;

o Assisted project managers with reports, documentation, and administration of projects in accordance

with Quality System Regulations.

Page 1 of 2

As the Subject Matter Expert for algorithm methods and software (C/C with a focus on clinical

applications to optimize results

o Initiated and spearheaded the algorithm development of two major projects:

A revised assay implemented on three instrument systems generating previously unrealized

revenue,

A new method producing expanded and clinically reliable results, planned for implementation in

the following generation of instruments;

o Developed methods and interpreted the data, relating the patterns to various disease states in

hematology and identifying problems within the data, wrote and examined software code;

o Analyzed data for evaluating instrument performance, diagnosing problems, and producing viable

solutions;

o Produced software and product specifications and documentation for design of algorithms in response

to customer or product requirements for a software release;

o Documented new and revised methods, software, and product specifications; presented methods and

product performance to cross-functional teams, management, and worldwide customer service;

o Investigated reported field problems; worked with Customer Service, Marketing, and Field Service to

resolve issues.

PUBLICATIONS & PATENTS

“Performance Evaluation of the Abbott Cell-Dyn 1800 Automated Hematology Analyzer”, Laboratory

Hematology 9:143-152, 2003

US 201********, Abbott Laboratories, “Method for flagging a sample”, 2/24/2011

Patent 8,390,624, DataDancer Medical Systems, “Interrelated graphical method for displaying blood pressure

data”, 3/05/2013

OTHER EXPERIENCE

Oct 2009 – Oct 2010 Volunteer Clinical Engineering, Saint Alphonsus Regional Medical Center, Boise, ID

Aircraft Navigator, United States Air Force

Biomedical Engineering Intern, Sutter Community Hospitals, Sacramento, CA

Clinical engineering training.

EDUCATION

Post-graduate study, Bioengineering, University of California, San Diego

M.S. Biomedical Engineering, California State University, Sacramento

Thesis: The Sensitivity of the Zepeda Electromagnetic Blood Flowmeter to Changes in the

Hemodynamics in the Vicinity of an Arterial Stenosis.

B.S. Chemical Engineering/Applied Biology, University of California, Berkeley

Page 2 of 2

Contact this candidate