Jenna Wagner Email & Phone Number

Cleveland, Ohio, United States

- Revising drawings to reflect the current model of pro2cool, a concussion therapy medical device - Editing DHF and DMR to update to the current stage of device development

Mentor, Ohio, United States

- Created and updated standard work for Washer Disinfectors and Decontamination Sinks- Created manufacturing supermarkets- Conducted a time study to balance the Decontamination Sink Line and participated in a week long Kaizen event to implement lean manufacturing practices- Worked to outsource a Decontamination Sink process

Cleveland/Akron, Ohio Area

JALEX MedicalMedical Device Design, Product Development & Regulatory Consulting: Accelerating Concept to MarketMedical Device Design & Development - Concept Generation and 2D/3D CAD- Medical Device Design per FDA regulations- Finite Element Analysis- Find manufacturing resources to create prototypes and production partsQuality - Quality Management System Development and Implementation per 21 CFR 820- ISO 13485, FDA, MDD, and Canadian Directive General and Facility Specific Training Programs- Company Representative during external audits by Regulatory and Third Party Auditors- FDA remediation assistance for 483 observations and warning lettersRegulatory- Regulatory Path Assistance & Product Classifications (Class I, II, III)- 510(k) submissions- Predicate Device Research - Device/Instrument Registration & Listing

Master'S Degree, Engineering Management

The Master's of Engineering Management (MEM) is a one-year joint degree between the Case School of Engineering and the Weatherhead School.

Bachelor Of Science - Bs, Biomedical Engineering