Leonard Dilts
Colorado Springs, CO ***** 719-***-****
https://www.linkedin.com/in/leonard-dilts-17179b17 ac78z8@r.postjobfree.com
Medical Device Quality Engineer
Data Analyses ISO Conversions Global Quality Initiatives
Quality engineering expert and Lean Six Sigma black belt, specializing in new product development, and manufacturing quality process qualifications / Improvements. Highly-analytical leader completing multiple complex development projects that begin with concept risk/hazard assessment and management; human factors testing and analysis; Verification and Validation protocols and clinical testing (bovine & porcine); and end with insightful reporting and documentation. Quickly identify defects through root cause analyses, and integrate improvements and corrective measures that result in streamlined processes and reduced operational expenses.
Project Management
CAPA and 483 management
Root Cause Analyses
Reliability Testing
Lean Six Sigma Black Belt
Verification & Validation
New Product Development
Lead Engineer
Process Qualifications
SPC (DataMite & WinSPC)
Six Sigma Black Belt
Quality Management Systems
Risk Assessments
Cost Reduction Efforts
PROFESSIONAL EXPERIENCE
BAXTER HEALTHCARE, Englewood, CO 2015 – 2017
Quality Manager - Supplier Quality & Incoming Quality Control
Oversee all onsite supplier quality engineers' processes, development, approvals, enhancements, qualifications, non-conformances (NCRs), and corrective actions (SCARs) for global quality integration.
Manage Incoming Quality Control (IQC) for inspectors, supervisors, and testing processes.
CONMED ELECTROSURGERY, Centennial, CO 2011 – 2015
Senior New Product Development (NPD) Quality Engineer
Developed streamlined protocols and reporting to conduct optimal analysis and testing of new product development for voice of customer (VOC) surveys and marketing requirements documents (MRD).
Established and applied hazard analysis, failure modes and effects analysis (FMEA), design requirements, and history file documentation for two new product development projects.
Served as lead manufacturing quality support engineer to ensure process qualification, assessments and correction of non-conforming material disposition.
Collaborated in process qualifications and requalification for seven Six-Sigma Kaizen events; and managed hazard analysis, dFMEAs, and pFMEAs for creation of two new products.
CEA TECHNOLOGIES, INC., Colorado Springs, CO 2006 – 2010
Senior Quality Engineer - Electro-Mechanical Surgical Devices
Sustained ISO 13485 compliance of product development by producing design requirements documents, leading verification and validation protocols and reports.
Conducted risk assessments and qualification of over 80 processes using DOE, IQ, OQ, PQ. Analyzed failure rate, reliability, and root cause analysis using statistical software such as Jump and Minitab.
Oversaw all value stream analysis, Kaizen, Six Sigma methodologies, and flow mapping for annual continuous improvement projects. Minimized quote time by 20% with improved RFQ process mapping.
Provided quality support engineer expertise to analyze return product failure, and introduced optimal corrective and preventive procedures. Lead engineer on dFMEAs and pFMEAs.
Saved over $7,200 in rework expenses with successful project completion that improved largest selling breast biopsy device by $600 per reworked device.
Implemented CMM inspection process for incoming and in-process inspections, including all work instructions and inspection planning.
Maintained process quality using SPC methodologies on five product lines.
AMETEK / DIXSON, INC., Grand Junction, CO 2003 – 2005 Senior Quality Engineer
Identified and contracted with international supplier for machined die cast housings that increased annual savings by $500K, machined brass connector saving an annual $875K, and high-pressure gauge assembly saving $150K annually.
Initiated and oversaw all dFMEAs, pFMEAs, IQ, OQ, PQ, product reliability, and time-to-failure analysis of new and redesigned product development projects.
Organized and led Material Review Board (MRB) root cause analysis; and corrective and preventive measures integrated for high-volume production of electro-mechanical processors and gauges for heavy truck, construction, military, and nuclear power applications.
Represented Nuclear Procurement Issues Committee (NUPIC) ensuring quality processes in development of nuclear power devices to meet compliance standards outlined in 10CFR50 Appendix B.
Aided gated product development process in conjunction with design for Six Sigma (DFSS), and led conversion from ISO QS 9000 to ISO TS 16949 compliant system.
ENTEGRIS, INC., Colorado Springs, CO 1999 – 2002
Quality Engineer - Microelectronics Division
Achieved 50% labor production costs reduction for three products to minimize 3,120 direct annual labor hours, and spearheaded new and redesigned product development test equipment design.
Evaluated all product failure testing, and reliability analysis data, and customer returned product analyses to determine deficiencies and integrate corrective and preventive actions (CAR).
Assisted in conducting thorough improvement analysis, reliability studies, and failure rate testing on three new high-profile products.
Developed automated laser inspection for critical high volume in-process inspections; including all inspection plans and SPC monitoring.
EDUCATION
Bachelor of Science in Chemical Engineering and Chemistry, Excelsior College of the University of the State of New York
TRAINING & CERTIFICATIONS
Six-Sigma Black-Belt - Air Academy Associates
Value-Stream Improvement Mapping - Lean Enterprise Institute (LEI)
Design for Six Sigma (DFSS) - Quality & Productivity Resources
Certificate of Quality Engineering (#38531) - American Society for Quality (ASQ)
Certificate of Quality Technician (#5861) - American Society for Quality (ASQ)
Reliability Engineering and Analysis - American Society for Quality (ASQ)
Certificate of Statistical Process Control Techniques – N.A.E.M.
ADDITIONAL PROFESSIONAL EXPERIENCE
IMI NORGREN, INC., Littleton, CO 1996 to 1999
Quality Technician (for airline and valve divisions)
Monitored and maintained statistical process controls for incoming and in-process inspections of Filters, Valves & Regulators.
WHALE SCIENTIFIC, INC., Denver, CO 1995 to 1996
Lead Quality Assurance Lab Technician (for Life Sciences division)
Monitored and maintained statistical process controls for in-process inspections of all blood screening and medical diagnostic kits.
MARQUEST MEDICAL PRODUCTS, AND SUBSIDIARIES, Denver, CO 1991 to 1995
Quality Control Supervisor (Preferred Mold and Engineering, Inc., Subsidiary of Marquest Medical)
Managed all incoming and in-process processes and inspectors.
Director of Quality Control (New Age Engineered Moldings, Inc. (Subsidiary of Marquest Medical)
Managed all incoming and in-process processes and inspectors.
First Article Inspector (Marquest Medical Products)
Managed and performed all First Article, and product qualification inspections.
PHARMACEUTICAL BASICS, INC., DENVER, CO 1990 to 1991
Quality Control Technician (Manufactured generic drug products)
Performed in-process inspections of generic drug products.