Brittany Dieter (Mccracken) Email & Phone Number

Amsterdam, Noord-Holland, Nl

• Coordinated biological testing with external certified testing laboratories (CROs) in accordance with ISO 10993 and ISO 18562.• Developed biological safety assessments to achieve ISO 10993 and ISO 18562 compliance to support new product development and legacy products.• Created biological safety impact assessments from manufacturing and supplier changes on patient-contacting devices.• Coordinated chemical characterization testing to ensure product / resin equivalency.• Lead & Consulted CAPAs on currently fielded products as the Biological Safety Subject Matter expert.• Participated in FDA 510k submissions and AI responses.• Updated/Implemented internal documentation including work instructions and protocol templates. • Created Internal technical documentation including biocompatibility assessments, formal technical reviews, protocols, reports and risk assessments.• Working knowledge of common manufacturing techniques and materials used in polymer molding/extrusion.• Performed gap assessments based on Technical File documentation for EU MDR certifications.• Reviewed manufacturers contact materials for compliance to EU MDR substances of concern regulations (e.g. RoHS and REACH materials)

Amsterdam, Noord-Holland, Nl

Amsterdam, Noord-Holland, Nl

• Coordinated biological testing with external certified testing laboratories (CROs) in the completion of ISO 10993 • Developed biological test strategies dependent upon patient contact and duration for new products in accordance with FDA, ISO 10993, and ISO 18562 guidelines.• Developed Biological risk assessments to determine potential biological risk to clinical trial participants.• Coordinated the completion of chemical characterization testing to ensure resin equivalency.• Assisted in an FTIR spectroscopic analysis to determine chemical equivalency between different manufacturers.• Performed gap assessments on existing products in order bring devices up to current ISO 10993 standards.• Evaluated Cleaning and Disinfection methods for patient interface products to AAMI TIR 12 and AAMI TIR 30.• Evaluated product design through performance and functional testing including baseline testing through end of life (accelerated aging) in accordance with 21 CFR part 820

• Ensure the continued success of the sterile disposables portfolio across 4 modalities including: MR, CT, CV and MI. • Support on-going efforts of maintaining regulatory compliance of sterile disposables • Qualify new materials for tubesets used in Angiography due to material obsolescence.• Qualify alternative bonding process for a significant maintenance cost reduction.• Logged defects and issues found during verification testing.• Qualify new tool designs for syringes across modalities used for fluid management.• Initiate biocompatibility in accordance to ISO 10993 with outside labs for all materials used in 8 existing and new product lines, which includes disposable catalog numbers for Class I and Class II medical devices. • Developed biological experimental plans to assess biocompatibility dependent upon patient contact and duration.• Held technical review meetings for disposable drawing updates and product requirement specifications changes. • Managed Corrective and Preventative Actions (CAPA) to successfully ensure completion of the project.

• Performed capability analysis on functional tests to show margin between the lower specification limit and the failure pressure. • Executed performance and functional testing personally as well as by managing up to 3 lab technicians.• Conducted shelf-life testing for new product development and legacy products (currently fielded) through accelerated aging.• Initiated and managed 3 Corrective and Preventative Action (CAPA) to ensure proper closure.• Conducted cleaning compatibility on both syringes and tubesets

Homestead, Pa, Us

Worked as a consulting engineer to provide clients with solutions for heating and cooling hydraulic systems and fire protection. Projects include: wastewater treatment facilities, firing range, commercial buildings and sprinkler systems.• Designed heating and cooling, pumping, plumbing and fire protection for nuclear powerplants and the department of Energy. • Performed fluid flow analysis simulation to calculate pressure drop and flow distribution in liquid and low velocity gas piping systems.• Performed Air Flow calculations using Hourly Analysis Program (HAP) to design commercial building HVAC systems. • Created 2D detailed design drawings of mechanical systems using AutoCAD. • Completed cost estimates for future architectural engineering projects to include preliminary work.

Homestead, Pa, Us

Provided Mechanical design support such as piping and HVAC for our clients. We take our clients ideas and make them become reality. Projects include: wastewater treatment facilities, firing range, commercial buildings and sprinkler systems.~ Utilized AutoCAD to design mechanical systems ~ Performed hydraulic modeling using Fathom. ~ Created P&I Diagrams ~ Created Bill of Materials ~ Created Cost Estimations ~ Communicated with customers and vendors.~ Participated in concept brainstorming meetings.

Beaver, Pa, Us

I completed an internship under head Clinical Engineer learning about different modalities. What they do, how they work, how do you fix them and design opinions from the everyday users as well as the engineers. I programmed different modalities such as CT and MRI. I also conducted tests on battery packs containing either lithium ion batteries or rechargeable batteries. This helped determine which battery performed better under certain circumstances. A cost analysis was also conducted to determine the battery life and the cost.

Master'S Degree, Bioengineering And Biomedical Engineering

Bachelor’S Degree, Bioengineering And Biomedical Engineering