I’m a consultant and lead product development engineer with Naglreiter Consulting. I provide a variety of services to NAGL MedTech clients, including process development, testing, fabrication, and product development. Specifically, I’ve contributed to several projects involving electrospinning for covered stents and shaft fabrication for micro & guide-catheters, aspiration catheters, and delivery systems.Although my technical skills are varied, I’m also an effective communicator and project lead. I’m able to efficiently work with clients to understand their needs and devise effective solutions. I’m also able to manage complicated projects and ensure that they’re completed on schedule and within budget.

Developed and validated over twelve catheter performance test methods (i.e.: Kink, Pull and Particulate extraction, etc) within a one year time frame. During that period supported catheter design efforts and assisted manufacturing with process development and equipment validations. Significantly contributed to the 510K submission and product qualification activities (Product performance,Packaging and Accelerated aging) prior to and post FDA approval.Developed and validated the GTIN label and barcodes used for all catheter products produced and sold worldwide.Ongoing responsibilities include production support (QC audits) and complaint handling (Product decontamination and complaint analysis).

Assisted project team with product development support, creating and performing test procedures and qualification testing for the Product Launch of the Amigo-A Insulin Pump June, 2008. Responsible for the ongoing R&D, validation and implementation of mechanical components for the Amigo-A Insulin Pump, performing multiple engineering evaluations and qualification testing.

Responsible for coordinating and performing engineering evaluations and qualification testing on multiple devices related to the treatment of Carotid Artery Occlusion, Abdominal Aortic Aneurysms and Vascular Access devices.Assisted various project teams with product and process development support through product analysis supplying direct feedback to the project teams. Assisted in the successful technology transfer of the Tributary 'Stent-Graft' Prosthesis and Delivery System from the Cordis Minnesota site to Miami.Responsible for setting-up the Tributary device pilot-line, trained operators and supported both research and process development with the knowledge learned from the transfer.Responsible for designing and creating the mold-inserts and gasket seal to prototype the first functional 13F sheath introducer and assisted with its development, performance and qualification testing.Generated and executed multiple Equipment and Process line Installation/Operation Qualifications, Test Method Validations protocols and reports.Responsible for the relocation, setting-up and maintenance of the AAA Endovascular R&D laboratory.Responsible for the design and fabrication of a Horizontal Deployment Machine frequently used to acquire and graph real-time force data for the delivery of Self-Expanding Stents and Stent-Graft Prosthesis.Coordinated and performed animal labs and/or bench top testing with engineers, marketing/sales reps and physicians.Managed the Non Standard Product Department, communicated directly with Physicians and sales reps in the field to build and supply unique or modified 'For Human Use' sheath introducers by limited quantities and criteria. Responsible for supervising two junior technicians assigned to the Non Standard Product department who assisted in the assembly, packaging, and qualification testing of the products post sterilization, prior to shipping to the physicians.

Performed field service repairs, personnel training, maintenance and refurbished Minolta and Sharp copiers.Company established field service technical efficiency based on my performance my 1st year with the company.