James J. Lew

ASQ Certified Quality Engineer (CQE) and Six Sigma Black Belt (SSBB) with broad quality engineering, manufacturing engineering, and validation experience across medical devices, pharmaceutical, electronics, aerospace, semiconductor, and R&D environments. Strong record leading NPI, QA sustenance, MRB/NCR/CAPA investigations, incoming inspection qualification, process validation, and Lean Six Sigma improvement initiatives that strengthen compliance, reliability, and production performance. U.S. citizen; former DoD Top Secret and DOE Q clearances.

Sr. Product Quality Engineer - Varian Intervention Solutions (Siemens-Healthineers) - Austin, USA

(2022-08)

Provide QA leadership for new product development, design transfer, launch, and sustaining production for Intelliblate MW Ablation, Cryoablation, Embozene Microspheres, and Everest product lines.

• Lead MRB/Q-Notes/IR/CAPA investigations, root-cause analysis, corrective actions, and cross-functional quality improvement activities.
• Drive statistical analysis and continuous improvement using SPC, Pareto, capability studies, MSA, hypothesis testing, ANOVA, DOE, and DMAIC methods.
• Lead validation and qualification activities across processes, equipment, software, facility, and cleaning validation; develop FAI and PSI inspection procedures for incoming parts.

Sr. Quality Engineer - Flextronics America - Austin, USA

(2020-02 - 2022-08)

Led QA start-up and qualification for RF Sterilization and SSA Factory operations; used Six Sigma analysis to identify process inefficiencies and drive improvements.

Sr. Quality Engineer - Philips/EGI - Eugene, USA

(2019-04 - 2019-09)

Supported design transfer and qualification of GTEN 200 Geodesic Sensor Functional Test system; strengthened in-line testing to reduce finished-product defects and improve final-test FPY.

Quality Engineer - Sedia Biosciences - Portland, USA

(2018-11 - 2019-04)

Validated new manufacturing and testing facility and production equipment and processes, ensuring compliance and enhancing operational efficiency

Sr. Process Engineer - Halyard Healthcare - Tucson, USA

(2017-11 - 2018-09)

Led installation/qualification of Oral Rinse Fill & Assembly System and Lean Six Sigma yield-improvement work using DOE, VMS, SPC, and NC investigations.

Manufacturing Engineer - Medtronic Neurovascular - Irvine, USA

(2017-05 - 2017-10)

Developed assembly aids and testing fixtures to improve efficiency and reduce process time; helped streamline the Resolute Onyx Drug Eluting Stent line, achieving FPY above 94%.

Advanced Manufacturing Engineer - St Jude Medical - Scottsdale, USA

(2012-08 - 2015-11)

Owned front-end auto-inspection/functional test and back-end rework/repair processes; led Lean Six Sigma initiatives that lifted back-end RTY above the 95% target.

Advanced Manufacturing Engineer - Honeywell Aerospace - Surprise, USA

(2011-02 - 2012-08)

Process owner successfully led 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 - Scottsdale, USA

(2008-01 - 2010-06)

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 MRB/QN support, NC investigations, continuous improvement projects

Quality, Process, Equipment, Project, and Military Engineering roles - Hynix/Infineon/Micron Semiconductor, Oak Ridge National Laboratory, USAF Weapons Laboratory

Held quality, process, equipment, project, and military engineering roles. Led production transfers, equipment installation and qualification, manufacturing sustainment, R&D demonstrations, and high-reliability aerospace/semiconductor process improvements.

M.S. - Electrical Engineering - Univ. of New Mexico (1990-12)

M.S. - Industrial Engineering - New Mexico State Univ. (1988-06)

MBA - Computer Systems Mgmt. - Webster Univ (1987-06)

B.S. - Chemical Engineering - Univ of Washington (Seattle)