James J. Lew
Austin,USA
Summary
Senior Quality Engineer with over 20 years of experience in the medical device and manufacturing sectors. Specializes in quality management and process improvement, demonstrating proficiency in defect investigation, risk assessment, and leading lean six-sigma initiatives. Achieves significant cost savings and defect reductions. Fosters a culture of quality through collaboration and strategic initiatives to drive continuous improvement and product excellence. Prepared to contribute to your organization by leveraging extensive experience in driving product quality initiatives and ensuring compliance with industry standards. Known for collaborative teamwork and flexibility in adapting to changing project requirements. Valued for reliability and results-oriented mindset.
Overview
41
41
years of professional experience
1
1
Certification
Work History
Sr. Product Quality Engineer
Varian Intervention Solutions
08.2022 - Current
- QA lead supporting the NPI, design transfer, qualification, and production sustenance of production of the Intelliblate Ablation devices
- Collaborating with cross-functional teams for product sustenance and enhancing product quality through initiatives to reduce incoming NC materials and fostering a quality culture both within and with vendors
- Leading the QA activities for three production lines identifying NC trends and root causes and applying strategic corrective/preventive actions with measurable results
Sr. Quality Engineer
Flextronics America
02.2020 - 08.2022
- Spearheaded QA activities supporting the start-up and qualification of the RF Sterilization and SSA Factory
- Conducted thorough data analysis to identify process inefficiencies, contributing to a six-sigma project that saved $10K monthly
Sr. Quality Engineer
Philips/EGI
04.2019 - 09.2019
- Provided QA support during the design transfer and qualification of the GTEN 200 Geodesic Sensor Functional Test system
- Implemented rigorous in-line testing protocol that led to a significant reduction in finished product defects and improving final test FPY
Quality Engineer
Sedia Biosciences
11.2018 - 04.2019
- Validated new manufacturing and testing facility and production equipment and processes, ensuring compliance and enhancing operational efficiency
Sr. Process Engineer
Halyard Healthcare
11.2017 - 09.2018
- Led the cross-functional team supporting installation and qualification the new Oral Rinse Fill & Assembly System, ensuring seamless production processes and on-schedule production launch
- Conducted thorough DOE analysis, identifying CTQ parameter solutions to attain the optimum production efficiency
Manufacturing Engineer
Medtronic Neurovascular
05.2017 - 10.2017
- Led initiatives to develop assembly aids and testing fixtures, increasing operational efficiency and reducing production errors and process time
- Collaborated with the cross-functional team to implement lean six-sigma methodologies to streamline the Resolution Onyx Drug Elution Sten production line, achieving a FPY exceeding 94%
Advanced Manufacturing Engineer
St Jude Medical
08.2012 - 11.2015
- FE (Auto-inspection vision system, FE functional testers) and BE Rework & Repair (R&R) processes owner
- Led the lean six-sigma improvement initiatives for the BE line resulting in a RTY above the 95% target
Advanced Manufacturing Engineer
Honeywell Aerospace
02.2011 - 08.2012
- Process owner successfully led the installation and qualification of the RLG Gyroscope Controller hybrid PCB assembly line, enhancing production efficiency and supporting expansion in PCB assembly capacity
Sr. Quality Engineer
Microsemi
01.2008 - 06.2010
- Lead QA supporting successful production-line transfer of the BE analog/RF device production and BE test lines from the Colorado factory to ensure product compliance &product quality during the transition
- Led the BE QA activities including NC investigations and implementing CAs to improve product quality
Sr. Process Engineer
Hynix/Infineon/Microns Semiconductor
09.1996 - 07.2007
- A process owner overseeing installation and qualification of the Diffusion/CVD wafer factory equipment and recipes supporting start-up and expansion and sustenance of the DRAM device production
Project Engineer
Oak Ridge National laboratory
02.1991 - 09.1996
- Project engineer leading the on-schedule field demonstration and deployment of the US DOE Portable Uranium Detector (PUD) devices
Engineering Officer (O-3)
USAF Weapons Laboratory
09.1984 - 01.1991
- Led the cross-functional military personnel and civilian contractors supporting the R&D and field demonstration of the high-power chemical laser systems at the USAF chemical laser facility (CLF) site
Education
M.S. - Electrical Engineering
University of New Mexico
12.1990
M.S. - Industrial Engineering
New Mexico State University
06.1988
MBA - Computer Information Systems
Webster University
06.1987
B.S. - Chemical Engineering
University of Washington
05.1984
Skills
- Quality Assurance Expertise
- Quality risk assessment
- Control plan development
- Corrective and preventive actions
- Proficiency in Lean Six Sigma Tool
- Lean manufacturing principles
- Proficient in process/SW validation techniques
Certification
- ASQ Certified Quality Engineer, current certification
- ASQ Six Sigma Black Belt (SSBB), current certification
Military Experience
- USAF, O-3, honorably discharged, KAFB, NM, 09/01/84, 01/31/91
- TN Air Guard, 126th SQ, O-3, honorably discharged, MTAGB, TN, 04/01/92, 04/30/94
Languages
Korean
Native or Bilingual
Affiliations
- American Society of Quality (ASQ)
Timeline
Sr. Product Quality Engineer
Varian Intervention Solutions
08.2022 - Current
Sr. Quality Engineer
Flextronics America
02.2020 - 08.2022
Sr. Quality Engineer
Philips/EGI
04.2019 - 09.2019
Quality Engineer
Sedia Biosciences
11.2018 - 04.2019
Sr. Process Engineer
Halyard Healthcare
11.2017 - 09.2018
Manufacturing Engineer
Medtronic Neurovascular
05.2017 - 10.2017
Advanced Manufacturing Engineer
St Jude Medical
08.2012 - 11.2015
Advanced Manufacturing Engineer
Honeywell Aerospace
02.2011 - 08.2012
Sr. Quality Engineer
Microsemi
01.2008 - 06.2010
Sr. Process Engineer
Hynix/Infineon/Microns Semiconductor
09.1996 - 07.2007
Project Engineer
Oak Ridge National laboratory
02.1991 - 09.1996
Engineering Officer (O-3)
USAF Weapons Laboratory
09.1984 - 01.1991
M.S. - Industrial Engineering
New Mexico State University
MBA - Computer Information Systems
Webster University
B.S. - Chemical Engineering
University of Washington
M.S. - Electrical Engineering
University of New Mexico