Description
Expert in hands-on new product introduction of highly successful medical devices. * Expert in running a manufacturing group within the process controls and documentation requirements of an ISO 13485 compliant environment. * Both low and high-volume production experience in a regulated, medical device environment as well as a passion for working on a cutting-edge, life-saving product. * Worldwide and Management Level Engineering, Manufacturing and Operations assignments with world leaders in Medical Devices. * Proven track record in managing transition from R&D to Manufacturing, start-up operations, global new product introductions and developing business strategies to leverage market growth. * Recognized expert in defining and developing complete manufacturing processes, advanced technologies injection molding, extrusion, precision machining and automation. * Excellent knowledge of FDA, GMP and ISO 13485 & 9001. * Verified and validated products and processes per CFR 21 FDA 820 regulations and ISO standards. Board Level Presentations, Concept to Commercialization Management, Product Development, Process Innovation/Improvement, Fiscal/Project Management, Leadership Development. * Abbott Labs QA Award (1988) Employee Excellence Award (1994) Chairman Award (1995).
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | Value Stream Manager | 7/2017 - Present |
| Air Xpanders Inc. | Developer Of An Implant Device Manufacturing Engineering Manager | 10/2015 - 7/2017 |
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