Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketing. Listed as inventor or co-inventor on 8 US/international patents and 20 submissions. BS Mechanical Engineering degree Expertise * Startups * FDA 510 (k) generation and submission * Product R&D/Prototyping * International regulatory submission * Medical Device Design Engineering * CE Mark technical file generation and submission * Verification & Validation Testing * Notified body ISO 13485 Quality Systems * Cleanroom Manufacturing & Engineering * Design Controls * Injection Molding & Extrusion * SolidWorks * Sterilization techniques and validations * Packaging Design

Highlights:

• Medical Device
• Emergency Medicine
• Surgical
• Engineering
• Research and Development
• Medical Devices
• Regulatory
• Qualify assurance
• Manufacturing