Daniel Taggart Email & Phone Number

Greater Denver Area

Greater Denver Area

Rugged Ozone Sterilization System (ROSS M1) research and development effort funded by the United States Air Force

Manage medical device development and testingManage contract funds, project budget, purchasing and timelineCoordinate contract sub-award involvement, budget, and timelineManage consultants and test contractorsCommunicate with FDA and Military PersonnelDevelop design verification and validation test plans, and US regulatory pathwaysDevelop FDA submissions and regulatory documentationAssure compliant and complete documentation, inclusive of DHFs and DMRs, to support successful and compliant product realization and FDA submission.Evaluate technical feasibilityEvaluate biomedical design considerations and engineering principles Hazard analysis (FMEA, CHA)Provides strategies, guidance and requirements to teams on requirements of 21 CFR 820Provides strategies, guidance and requirements in the areas of development, risk, test, verification and validation.Support new product and development process, Design Reviews and all aspects of Design Control, including: quality planning, control plans, and risk analysis.Develop and document tests and experiments, provide structure for sample traceability, data documentation, and perform data reviews.Provides technical support on manufacturing and design issuesReviews and/or comments on technical content of intra- and inter-departmental reports.Performs internal audits; conducts vendor and supplier evaluations and/or audits to verify capability and/or compliance.Consults with quality experts to ensure that quality activities are performed in accordance with Ceramatec’s 21 CFR 820 compliant design control system and in accordance with the FDA’s Quality System Regulations.Acts as a Management Representative as defined by FDA Quality Systems Regulations (21 CFR 820.20(3)) and ISO 13485 (§5.5.2).

Greater Salt Lake City Area

Ceramatec, Inc. - Medical Responsible for all aspects of the Medical Device Quality Management SystemQuality engineeringResearch and development engineeringAssuring compliant and complete documentation for medical device development:Inclusive of Design History Files and Device Master RecordsSupport successful and compliant product realization and FDA submissionWork with a cross-functional team and outside consultants to assure each medical device development process is in compliance with US and EU medical device regulations.Perform activities associated with each phase of research, development, production, and testingConsulting with quality expertsDocumenting test protocols and reports

Greater Salt Lake City Area

Biomass Research and Development InitiativeElectrochemical synthesis (dimerization)Ionic Liquid synthesisGCMS

Greater Salt Lake City Area

Ceramic material manufacturing for oxygen transport membranes

Bioengineering

Work focused on development of medical bone adhesive, for Dr. Russell StewartPublication of results in special silk edition of Biopolymers (volume 97, Issue 6)Utilized scanning electron and optical microscopy (confocal/polarized) to characterize insect gland structure/function and develop understanding of aquatic fiber formation mechanisms. Explored chemical markers in natural silk and silk precursors in vitro with immunohistochemistry, ionic dyes, specific stains, and polarized light. Collaborated on other researchers projects focused on synthesizing complex coacervates. Coordinated and lead lab discussion, and extensive presentations on project research.

Education record

Bachelor Of Science (Bsc), Biomedical Engineering