CAREER OVERVIEW
Achiever • Analytical • Mentor • Motivational • Arranger
Decisive, analytical, dedicated, and result-focused professional with a proven track record of resource management, high volume manufacturing, data analysis, and test automation in the fields of telecommunications, computers and biomedical industries. Offer outstanding talents in CAPA, 8D / DMAIC / DMADVV, budgetary management, process improvement, complaint handling, root cause analysis, process verification/validation, project management, customer relations, mentoring, FMEA/DFMEA/PFMEA, design/product transfer, FDA 21 CFR 820, FDA 21 CFR 11, and ISO 13485. Driven by challenges and the desire to be successful in all endeavors. Willing to travel >50%.
PROFESSIONAL EXPERIENCE
Central Engineering Manager Jan. 2013 – Nov. 2015
Terumo CV Group Ann Arbor, MI
Hired, developed and managed the Central Engineering Team (12+ direct reports) of Engineers and Technicians responsible for product design – transfer - verification – validation – sustain - retirement, complaint analysis – root cause – correction – recall – 510k.
• Managed and led cross functional Engineering team (Mechanical/Electrical/Chemical) through all phases of multiple CAPA projects associated to FDA remediation activities resulting in an estimated annual cost reduction of over $3M
• Vital part of attaining re-certification and the lifting of shipping restrictions – FDA consent decree
• Drove 92 active PD CAPAs and resolved/closed 80 in less than 2 years
• Supported business essential review boards – CRB, CCB, MRB, QRB
• Worked with the claims, service, and quality teams to improve or develop actionable metrics
• Travelled to Terumo Japan (Tokyo / Fujinomiya) to assess and resolve product-related issues with our customers
Data Analyst, Data Management Jan. 2009 – Nov. 2012
Motorola Mobility – division of Google Libertyville, IL
Developed and enhanced the global Motorola Mobility claims data management solution (+500k claims per month)
• Took ownership of the deprecated claims database running on Microsoft Access
• Re-designed, and consolidated global database using Microsoft Access
• Ported MS Access db to MySQL server
• Achieved reduction in process time of the Motorola Mobility Quality and Financial reports from 120 man-hours down to 10 man-hours while adding functionality, error checking, and actionable metrics
• Built an Ubuntu Linux server running MySQL database server to host local users
• Heavily modified Excel workbooks to import data from server and export in graphical form
Staff Senior Engineer – SEPG Leader Jan. 2001 – Dec. 2011
Motorola Mobility Libertyville, IL
Leader of the New Product Introduction Team – responsible for the introduction, tracking, management and disposition of new CDMA market products in USA. Worked closely with Verizon Wireless, AT&T, and other national carriers – new requirements, complaints.
• Complaints analysis – root cause investigation – design changes
• Corrective action prioritization – field failure prediction
• Liaison between north America carriers and Motorola New Product Introduction
• SEPG Leader – implemented CMM Level 2 / 3 software development process
• Conducted on-site training and IPA evaluations to 50+ associates
• Performed SQA audits – led SEPG (Software Engineering Process Group) and IKPA (Integrated Key Process Area) initiatives
• SAS Analyst certification
Staff Test Engineer Aug. 1998 – Nov. 2000
LifeScan / Johnson and Johnson Milpitas, CA
Project Leader of the hospital blood glucose meter designed to support 999 patients – precursor of the SureStepFlexx
• Developed the automated test and calibration solution for manufacturing
• Recruited and led a team of software development, hardware design, and V&V Engineers
• Team developed object oriented test environment platform – became LifeScan standard developing environment
• Managed Flextronics – contract manufacturing – to build, document, and validate two test stations for a total of $1.5M
• Defined, developed and deployed calibration and verification solutions (software and hardware) for the production of high volume electro-chemical glucose meter in China
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