Eric Andrews Email & Phone Number

Minnetonka, Mn, Us

Minnetonka, Mn, Us

Minnetonka, Mn, Us

Minnetonka, Mn, Us

Minnetonka, Mn, Us

Minnetonka, Mn, Us

St. Paul, Minnesota, Us

I supported the Amplatzer device and delivery system manufacturing lines with a wide range of activities. Focus area included delivery system manufacturing which involved processes such as UV bonding, tip reflow, and injection molding. Activities have included: Running full validations(IQ, OQ, PQ) on process improvements. Perform characterization and design of experiments to optimize process parameters. Working with Regulatory and R&D to resolve CAPA related issues. Redesigning of mold tooling and processes including qualifying new injection molding machine for production use. Troubleshooting equipment, reviewing prints to ensure proper GD&T and design controls. Oversee the Amplatzer yield reporting including formal yield improvement projects and cost reductions.Major goals were to drive improvement to processes to limit variability and enhance quality.

St. Paul, Minnesota, Us

Provide Quality Engineering leadership to manufacturing by developing and maintaining product risk management documents (FMECAs, etc.) throughout the product lifecycle.Lead CAPA activies, nonconformance (NCMR) investigations, supplier activities, and complaint investigations for commercialized product ensuring that opportunities are thoroughly communicated, addressed and efficiently resolved.Mistake-proof manufacturing processes to ensure product performance meets pre-determined requirements.Initiate and/or approve Engineering Change Orders, Manufacturing Inspection Procedures, Verifications, Validations, and other documents as required.Design, develop, and validate test methods to evaluate incoming components, in-process inspections, and finished goods for conformance to specifications.Perform analysis and identify trends in Quality data, driving improvement actions accordingly.Update and train others on Quality System and Manufacturing policies and procedures to ensure department efficiency and compliance to regulations.

Plymouth, Mn, Us

• Supported R&D, Design Assurance, Quality Assurance, and Production in many areas including special work request submissions, time studies, and test method development. • Created test methods that are used across different R&D projects, improving test methods to become repeatable and reproducible through implementation of a new measurement system assessment procedure using MiniTab Statistical Software.• Created specifications through competitive product statistical comparisons and submitted these in Product Specification Matrices• Determined need for prototype test fixturing and created in SolidWorks 3d cad software. Created applicable drawings in formats following company standards that machinists and metal working companies can effectively understand and create• Support design verification testing through data collection and analysis• Create dFMECA, uFMECA, and pFMECA documents in FMEA-Med8 software through knowledge of the product and communication with R&D Engineers. Created and assessed risks in a risk management plan. • Reviewed different devices’ occurrence ratings through assessing complaint data and tracing those complaints to specific harms.• Core team member of a product in development and coordinated with extended team members to ensure deliverables(biocompatibility, sterilization, IFU’s, and pFMECAs) were on schedule and on task

Maintained, repaired, and filled bars, food stands, and warehouse.Received team of the month award twice during live race season in a workplace of 500 people with attendances of up to 18,000 people.

Quality Engineering Intern:Supported Medical Device Directive 2010 Compliance through gap analysis and technical file review.Implemented statistical process control and monitoring on current AMS product through coordination with intern in process engineering.Performed spot check verifications on manufacturing floor which involve making sure the technician is following the correct up-to-date procedures by the approved quality system.Created a human use review presentation which involves high level management approving the designated specifications that will ensure the product is safe to use in a human beingWomen's Health R&D Intern: Supported truth seeking Rabbit Animal Study in the area of mesh design and coating.Performed all data analysis of tensile properties of tissue.Improved testing and implantation procedures through immersion and careful note taking.Coordinated with team of 5 professionals on updates and conclusions that were shown through the data.Helped the company achieve a major goal of getting a Women's Health Division feasibility team into the formal design process by end of Quarter 4 through conclusions drawn by the testing and data analysis performed.