Host of The Packcast, a podcast focused on bridging the gap between web2 and web3. Learn more about the people behind the pixels.

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Disciplined product development within a cross-functional team of engineers, clinicians, entrepreneurs and industry professionals to target unmet clinical needs for the purposes of developing medical devices.Focus areas include: Orthopedic Surgery, Pediatrics, Healthcare System Savings, Heart Failure, Veterinary MedicinePrimary responsibilities include:- Medical Device Development: Concept/Solution Generation, Prototyping, Market Research, Regulatory/Reimbursement Pathways, IP Research, Business Plan Development and Strategy- Clinical Immersion: Needs collecting, filtering and downselection, collaboration with physicians/researchers/medical device professionals- Mentor and advise Senior Design teams

US Divisional Support - Supporting Europe, Middle East, AfricaImplantable Electronic Systems, Atrial Fibrillation, Cardiovascular, Capital Equipment• Prepare new product submissions, renewals, notifications and amendments for international markets• Communicate and coordinate regulatory activities with other departments• Review product and manufacturing changes for compliance with applicable regulations (Change Control)• Manage product approval records and prepare product release documentation per department procedures• Coordinate with departments to ensure smooth product release and phase out• Provide support for regulatory operations to ensure products being imported into international markets are meeting local requirements• Work with US and International team members to ensure efficient outcomes• Provide international lead support for new product roll-outs in markets outside of US/EU/Canada and Australia• Perform Engineering Change Order reviews for labeling updates

AF/EP Devices and Capital Equipment• Assessed complaint to determine if an adverse event report needs to be filed with various global regulatory agencies (e.g. FDA, European Competent Authorities, TGA) • Communicated verbal/written both internally/externally regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), • Investigates complaints/events in a timely manner and initiated/managed complaint files• Maintained accurate entry of complaints in database• Prepared customer response letters with findings• Participated in cross-functional complaint review groups on a regular basis or as requested• Supported inspections by regulatory agencies as requested• Supported complaint database upgrades and conversions by providing input and performing system testing• Ensured accurate department procedures and work instructions were followed and maintained

• Assess the commercial viability of new inventions, review of patent literature, developing marketing materials, and identifying potential licensees• Work in collaboration with Technology Strategy managers who assess new technologies and manage the patenting process

• Conducted non-clinical Good Laboratory Practices (GLP) critical phase audits, ensuring that the testing and reporting of results were completed in a timely and accurate manner under the guidelines set forth• Assisted and worked with laboratory technicians/associates across 6 departments (In-life, In Vitro, Genotoxicology, Chemistry, Mycoplasma, and Microbiology) to ensure testing was done according to the protocol• Conducted GLP final report audits• Participated on process improvement teams• Conducted reviews of batch records and issued Certificates of Analysis (CoA)• Lead quarterly training on Good Documentation Practices (GDP) for all new hires• Maintained quality level in all areas of laboratory services and notified QA Director, Lab Directors and/or all applicable parties of potential sources of problems, deviations and/or non-compliance • Performed internal audits • Provided assistance in performance of all QA functions such as SOP writing and review, audit follow ups, occurrence meetings, and committee participation• Assisted in maintenance of Quality Systems such as; Corrective and Preventive Action (CAPA), deviations, root cause analysis and laboratory investigations • Performed tasks in compliance with applicable Code of Federal Regulations, International Standards (ISO), WuXi AppTec policies and Standard Operating Procedures (SOP)

• Ensured the quality of products that entered and left the facility met Nestle standards of food safety• Followed Good Manufacturing Practices (GMP), GLP, Hazard Analysis and Critical Control Points (HACCP), CAPA, GDP and ISO 22000• Assisted the production and warehouse teams when a quality presence was deemed necessary in the event that products/raw materials were out of specification, and/or a deviation arose • Executed a range of pre/post production tests on all products produced from the powder, liquid and aseptic lines • Verified, sampled, and tested all raw ingredients received at the facility from vendors• Performed packaging testing on all incoming shipments• Accepted or rejected raw materials if deemed to be out of specification at time of arrival• Carried out a wide variety of verifications; Clean-In-Place, new line start up, x-ray kickoff, packaging quality• Performed safety, GLP, and GMP audits• Performed quarterly refresher presentations on quality standards• Created and updated SOPs, and other laboratory documents• Performed environmental monitoring • Performed validations on new test procedures