Engineering Engineer
Resume:
RICHARD HINDERS
TEMECULA, CA, 92591
***********@*****.***
SUMMARY
Engineering professional with diverse experience in manufacturing engineering, quality engineering, and reliability engineering. Considered to have expertise in CAPA, DOE, statistical analysis (quality and reliability), equipment and process validation, test method design, 6M techniques and problem solving. Past products and peripheral areas include: angioplasty accessories, guide wires, dilatation catheters, metal stents, drug eluting stents, extrusion, injection molding, reliability engineering, R&D Engineering, and CAPA Engineering.
Additional hands-on experience includes Auditing, SolidWorks, technical drawings, SPC, A3, Microsoft Suite, machining, management presentations and 30-day notice submissions. Can travel domestic or international on short notice. EDUCATION AND PROFESSIONAL CERTIFICATIONS
PALOMAR COLLEGE, San Marcos, Ca.
A.A. in Engineering, May 1990, GPA 3.25
NATIONAL UNIVERSITY, Rancho Bernardo, Ca
B.S. in Manufacturing Design Engineering, October 2012, Cum Laude SAN DIEGO STATE UNIVERSITY, San Diego, Ca
M.S. in Regulatory Affairs, 85% complete, Graduation TBD, Current GPA 3.85 CERTS
ASQ-Reliability Engineering, ASQ-Quality Manager, ASQ-Quality Engineering, ASQ- Quality Auditing, Abbott-Six Sigma Green Belt, Abbott-CAPA Investigator and Resolution Planner
WORK EXPERIENCE
9/16 to BrightWater Medical, Temecula California
Present Senior R&D Quality Engineer, New Ureteral Catheter Development Responsible to perform Quality functions including audit preparation, risk analysis using FMEA techniques, develop CAPA Procedures, Incoming Receiving Procedures, and various validations. Projects include: Calibration Scheduling, laser marking process development (laser programming and fixture design), label design for sterilization and packaging validation, software validation.
4/16 to Covidien-Medtronic, Irvine California
9/16 Senior Reliability/CAPA Engineer, New Product Development Group CAPA team member responsible for resolving ANVISA GMP findings. Page 2 of 3
Richard Hinders
11/15 to Bright Water Medical, Temecula California 4/16 Senior R&D Quality Engineer, New Renal Catheter Development See work experience BrightWater Medical, 9/16 to present 2/85 to
6/15
ABBOTT VASCULAR (Formerly GUIDANT), Temecula California 1/12 to
6/15
CAPA/ME Engineer, CAPA representative for all AV Products and Quality Functions Manufacturing Engineering Department
Responsible to manage and direct 4-6 CAPA’s per year with minimal supervision while maintaining required timelines.
Responsibilities include creating and supervising ad hoc teams to resolve CAPA issues, conduct root cause analysis via 6M techniques, define and implement global resolution plans, determine risked based acceptance criteria, and track CAPA metrics to determine if resolution plan is meeting predetermined acceptance criteria. CAPA’s include: Scrap Reduction, Production Complaints, Audit Response, Quality System gaps and Customer Complaints. 6/09 to
1/12
Principle CAPA/ME Technician, Endovascular Products, Dilatation Catheters and Balloons Manufacturing Engineering Department
Project lead for low-pressure balloon rupture CAPA for Xience-V product, implemented revised engineering testing that eliminated adverse effects to balloon material thereby reducing false- positive rupture scrap by 95%. This realized a sustained annualized savings of $1.36 million WW.
Supervised a five-person crew to develop and validate the Xience V particulate test when FDA rejected the filing data for particulates. The first particulate validation report written by our team was accepted by the FDA, which expedite Xience-V approval. Passed the Abbott Investigator, Resolution Planner Awarded 6 sigma Green Belt certification
Added as a permanent member to ME CAPA group July 1, 2010. Received Engineering Excellence Award in 2010 for Xience-V low pressure rupture CAPA. 8/05 to
6/09
Expert R&D Technician, Drug Eluting Stents and Xience-V Subassembly DES R&D Engineering Department
Worked within DES team to reduce Xience-V line scrap and increase daily production throughput. Project lead for DES Balance Weighing throughput project, which reduced balance induced line scrap by 80% while increasing balance efficiency by 30 percent. Received Engineering Excellence Award in 2008 for Xience-V balance CAPA. Page 3 of 3
7/03 to
8/05
Richard Hinders
Expert R&D Technician, Stent Delivery, Teflon Balloon Development Team R&D Engineering Department
Work as team member on the Teflon Balloon development team. Developed ePTFE tape specifications for Receiving Inspection and implemented on-line inspections for finished devices. Conducted various DOE’s related to process development, created documentation, managed production and engineering resources to oversee Engineering Builds for reliability evaluations. Presented management updates regarding reliability test results and manufacturing challenges. 1/02 to
7/03
Expert Process/Quality Technician, Responsible for Guide Wires and Stent Delivery Systems Quality Engineering Department
Work as QE to reengineer existing processes, create and develop risk analysis for post-production product improvements. Also, validated new test procedures for stent delivery systems. 7/97 to
1/02
Principle Reliability Engineering Technician, Quality Development and RE Test Lab Quality Development and Testing Department
Responsible for purchasing and qualifying equipment, developing new test methods, test data integrity and audit SME for both Temecula and Santa Clara RE Labs. Passed two internal and one external FDA audit with zero findings or observations. Main responsibilities include test method development for Guide Wires, Dilatation Catheters and Stent Systems. Additional responsibilities include software validation, equipment qualification, data analysis for project teams and provide technical training to lower level technicians. Developed, validated and implemented the balloon compliance test, the stent irreversible deformation test, the DES particulate test and the stent dislodgement test. Placed on talent retention status in 1997,1998 and 2002. Personal I was raised in San Diego, California. My interests include drumming, and coaching youth football.
I fulfilled my military obligation by serving four years with the 101st Airborne/Air Assault Division, light combat infantry. Successfully completed the 101st Recondo Leadership School (Combat Leadership and Reconnaissance Training).
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