David L. Kuhns                           

Career Objective:       

A Professional Quality opportunity where QUALITY is not only talked, but also walked.  Where the management philosophy and practice is customer driven.  Where statistical expertise and a sound quality understanding are utilized to its fullest potential. 

Profile:

A cross functional team player who understands the people who know their own processes.  A creative problem solver who listens to the innovations expressed by the team members, and can assist those members in the productive development of their ideas.  A skilled craftsman in designing, implementing, and analyzing statistical proof of process improvement, validation, and evidence of effectiveness.

Career Accomplishments:

s         Played a key role in developing sound quality systems to comply with ISO-9001.  As a result the division achieved the C.E. mark and received the best results of the ISO audit within the corporation.  Achieved 99% catheter yields and less than 0.4% field returns on a complex diagnostic catheter (multi-electrode array).  Reduced scrap by 76%

s         Successfully implemented a complete quality system including all regulations for ISO9000, EN13486, Medical Device Directive (MDD) and Good Manufacturing Practices (GMP) requirements.

s         Key resource in applying regulatory compliance issues for FDA submissions including Pre-Market Approval (PMA) and 510(k); along with clinical study design and evaluations through IDE submission and completion.

s         Auditing and corporate resource with management responsibility for EU and FDA audits.

s         Applied Design of Experiments to a fluidized bed process utilizing a factorial design nested within a mixture model in order to resolve a difficulty in pharmaceutical taste masking and manufacturability.  To the knowledge of the company and the customer this was the first time that this process was successfully used in this type of application.

s         Headed a wide-ranging corporate team to comply with and achieve the Ford Q-101 rating.  This was in a plastics molding facility and accomplished before Ford Plastics Products Division won the same award.

Publications:

s         Statistical Tools for Process Control, A Workshop

s         The Application of Queueing Theory to Manufacturing Processes.

s         A Practical Approach to Design of Experiments,  Merging the Traditional with the Modern.

Professional Experience:

s         Continuous Quality support of manufacturing.

s         Prospective and retrospective validation of manufacturing processes.

s         Regulatory compliance and submissions and reporting including PMA, 510(k), IDE, Vigilance and MDR reporting.

s         Design of Experiments for clinical studies, manufacturing process improvement, optimization and validation.

s         Investigation of government and private statistical findings, demonstrating inconsistencies in analysis.

s         Taught more than 2000 people in Statistical Process Control, Team Problem Solving, and Design of Experiments.

s         President, Minnesota State Chess Association (600 members).

Education and professional development:

Bachelor of Statistics, University of Minnesota, Institute of Technology, 1985

Bachelor of Mathematics, University of Minnesota, Institute of Technology, 1973

Member, American Society for Quality (ASQ)

ASQ Certified Quality Engineer, 1989

Member, American Statistical Association (ASA)

Certified National Tournament Director, United States Chess Federation

David L. Kuhns

Employment history:

Endocardial Solutions, St. Paul, MN                                                                                                                                                1998 to Present

Principal Quality Engineer/ Statistician

Manufacturing development and improvement.  Design of Experiments, Clinical (IDE) Analysis, GMP, ISO900 compliance, validations and qualifications, and statistical applications to manufacturing.  510(k) and IDE writing and submission for FDA, vigilance and MDR reporting and other interaction with regulatory agencies.

Manpower Technical – Medtronics, Tachyarrhythmea                                                                                                                 1997-98

Senior Materials Quality Engineer, Temporary Contract Assignment

Supplier quality and concerns, new component qualification and testing.

SIMS Deltec, St. Paul, MN                                                                                                                                                  1996 - 97

Senior Materials Quality Engineer, (Reorganization layoffs)

Supplier quality and concerns, quality audits based on ISO, MDD and GMP requirements.  Incoming inspection, validations, qualifications.  Supplier negotiations for pricing, conformance to requirements, supplier certification, inspection plans and statistical analysis.

B. Braun Medical, Mpls, MN                                                                                                                                                               1995 - 96

Quality Engineer and Statistician,  (Facility closed)

Key role in implementing ISO 9001.  Validation of complete medical device processes including PTA Balloon Catheters, Introducers, and other cardiovascular surgical devices.  Retrospective validations of manufacturing process and continuous quality support of medical device manufacturing.  510(k) and IDE writing and submission for FDA, vigilance and MDR reporting and other interaction with regulatory agencies.

CIMA Labs Inc., MN                                                                                                                                                                             1994 - 95

Validations Engineer and Statistician,  (Start-up venture, mass layoff due to customer cutbacks)

Validation of OTC drug manufacturing processing, including fluidized bed granulation and overcoating processes, tablet formulation, taste masking, blending, tableting and packaging.  Construction of a GMP facility and validating the systems of that construction.  Assisted Research and Development with design of experiments for taste masking and evaluation. 

Minntech Corporation, Mpls., MN                                                                                                                                                     1992 - 93

Corporate Statistician and Quality Assurance Engineer, (Mass layoff due to problems with FDA)

Implementation of systems to comply with FDA GMP regulations and ISO 9001 standards.  Manufacture of cold sterilants for medical device reuse such as Dialysis filters and catheters; the automated electronic equipment for their use; high flux dialysis filters, hemofilters and concentrators; oxygenators and heat exchangers for cardiovascular surgery.  Responsibilities included the design and analysis of clinical studies; investigation of reported statistical findings; and quality engineering of the fiber products.

Product Design and Engineering, Mpls, MN                                                                                                                                  1990 - 92 

Quality Assurance Manager,  (Facility closed)

Implementation of a complete quality and documentation system.  Taught SPC, Team Oriented Problem Solving, and Designed Experiments.  Injection Molding.

UFE, Inc., Stillwater, MN                                                                                                                                                                     1986 - 89

Corporate Quality Engineer, (SPC Facilitator in 4 locations)

Implementation of SPC on a corporate scale with 'dotted line' supervision to the plant facilitators.  Taught SPC to 100% of the employees. Revised and rewrote the Quality Assurance manuals.  Achieved the Ford Q-101 rating for the company.  Custom injection molding and assembly.

Control Data Corporation, Magnetic Peripherals Division, Bloomington, MN                                                                         1979 - 86

Senior Industrial Engineer, SPC Facilitator

Implementation of SPC, taught 100% of the employees SPC in the facility (450+).  Electronics, computer disk drive assembly.  Validated a 9000 square foot class 10 - 100 clean room.  President's Award for cost reduction.  Control Data laid off approximately 9000 employees in 1985 - 86.

1971-1979 Various Industrial and Quality Engineering positions.