Description
Summary of experience Extensive experience in Medical Device Design, Development and Manufacturing Quality: New product Design experience: 10 new product design projects, and over 30 product redesign projects Design Input: VOC, Risk Analysis (HA & dFMEA), MRD, DRD Design Output: Verification & Validation testing (ex - & in-vivo, human factors & clinical) Mfg. Qualification experience: IQ/OQ/PQs, DOEs, MSAs, GR&Rs Six-Sigma (Kaizen) experience: Three green belt, and four black belt Kaizen projects. Accomplishments: * Completed multiple product redesign projects including two new product development projects. Initiated, lead and completed two new product Hazard Analysis, dFMEAs and pFMEAs. Participated in 7 product improvement projects (Six-Sigma Kaizen events). * Participated in over 30 processes qualifications/re-qualifications (IQ, OQ, PQ). * Completed 5 Continuous improvement projects: * Sr. Quality Engineer 2006 to 2010 * CEA Technologies, Inc. 1755 Merchants Court, Colorado Springs, CO 80916 * Electro-Mechanical Surgical Devices Responsibilities: Maintained compliance to ISO-13485. * Product development responsibilities included: Design Requirements Documents (DRD) Verification & Validation (V&V) protocols and reports: Risk/Hazard analysis documents: HA, FMEA, process qualifications (DOE, IQ, OQ, PQ), and failure & reliability analysis. Note: all data analysis was performed using MiniTab. Two annual continuous improvement projects (Six-Sigma, Value-stream analysis, Kaizen, Flow mapping, etc.). * Manufacturing quality support engineer. * Return product failure analysis including corrective & preventive action implementation. Accomplishments: Lead engineer on 2 dFMEAs and 5 pFMEAs. Validated over 80 processes using IQ, DOE, OQ, PQ. Continuous improvement projects: * Reduced rework costs on largest selling breast biopsy device by $600 per reworked device ($7,200 annual savings). Process mapped RFQ process to reduce quote time by 20%. * Streamlined pFMEA process using team appraisal to establish baseline values for standard manufacturing processes.
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