Company management is led by President, Brett Naglreiter, in combination with an seasoned executive leadership team.
Brett Naglreiter, MSME
Brett is at the helm of Naglreiter with over 24 years of medical device experience working with large organizations to startups. Brett has leveraged his extensive development expertise to create an industry-leading medical device development organization, which possesses the passionate expertise, professional experience, and proven processes to deliver unsurpassed medical device development services. A clear and decisive leader, Brett is known for building and leading teams, developing talent and delivering results. Over the course of his professional career, Brett has held several roles. Brett was the VP of Engineering and Interim COO for Apollo Endosurgery, Inc. – a venture-backed medical device company focused on developing flexible therapeutic surgical products. At Apollo, Brett turned an initial investment of $40M into $137M. Prior to Apollo‚ Brett served as VP of R&D and interim COO for VeinRx, Inc.‚ a venture backed medical device company developing advanced catheters for drug delivery with supporting software solutions. While at the helm of VeinRx, he managed the product development process from concept through completion. Before joining VeinRx, Inc.‚ Brett managed the completion of the LifeStent technology transfer‚ a Syntheon project for Edwards Lifesciences. Additionally, Brett served as the program manager and lead designer for both the Orbit and the Trufill Detachable Coil systems at Cordis Neurovascular. During his tenure, Cordis Neurovascular’s annual revenue grew from $5‚000‚000 to $63‚000‚000. Brett holds a Master of Science in Mechanical Engineering from Stanford University and a Bachelor of Science in Mechanical Engineering from Clemson University. He currently consults for companies across the US in various technical, strategic and leadership capacities.
With over 13 years of experience in medical engineering, quality assurance and regulatory affairs, Veronica is well positioned to manage the regulatory and quality control functions which are critical for launching any medical device. At Naglreiter, Veronica helps insure we’re doing everything with quality assurance in mind. She brings extensive experience with Quality Management Systems, product and process development and qualification/validation, FDA and ISO regulations, Regulatory Submissions, Design Controls and Six Sigma and Lean methodology. Prior to joining Naglreiter, she was a Quality Assurance Engineer for SafeStitch Medical where she was responsible for developing test methods for advanced R&D products and review/approval for design and process qualifications. Before working for SafeStich, Veronica was a Senior Engineer at Cordis Johnson & Johnson where she was responsible for ensuring manufacturing readiness in accordance with quality, regulatory and operations requirements. She holds a Bachelor of Science in Mathematics from Stetson University.
Ed Ampuero, BSME
As Product Lifecycle Management Director at Naglreiter, Ed leads the design and development of the organization’s technology in preparation for clinical trials and commercialization. With nearly 15 years in the medical device field, Ed’s experience ranges from large companies to start ups. Prior to joining Naglretier, Ed was a Senior Engineer at Depuy Orthopedics where he led the project engineering team through all phases of design, prototype and testing activity to ensure timely completion of project deliverables. Before his role at Depuy, Ed was a Design Engineer at VeinRx where he was responsible for developing the engineering processes and revised component design in order to improve manufacturability. Prior to VeinRx, he held senior engineering roles for Syntheon and the Environmental Aeroscience Corporation where he was responsible for the design, testing and delivery of critical components and improving production efficiencies. Ed holds a Bachelor of Science in Mechanical Engineering from Florida International University.
Deb is the Controller for Naglreiter where she is responsible for all aspects of financial reporting. Deb’s main focus is to ensure everything adds up. With over 18 years of experience as an accountant, controller and CFO, she oversees all accounting functions. Prior to joining Naglreiter, Deb was the controller for D. Lundgren & Associates, her own accounting firm, where she provided all accounting functions for small- to medium-sized companies. Prior to starting her own firm, she was the controller for Hollywood Atlantic Real Estate Group where she prepared financial statements on a monthly, quarterly and annual basis for multiple types of clients. She is proficient in all the latest accounting software including QuickBooks, Spectra, Yardi, Logitch-Domain as well as Excel. Deb holds a Bachelor of Science in Accounting from Winona State University of Minnesota.
A results-driven and highly-skilled engineer, Elias is Naglreiter’s Operations Manager where he oversees day to day facilities and engineering equipment management. With over 19 years of engineering experience and a successful track record of working on complex projects that bring new medical product to market, Elias is a natural fit for this role. Prior to joining Naglreiter, he was a Senior Engineer at Applied MedTech where he carried out the development and design activities surrounding the launch of radiation oncology devices. Before his role at Applied MedTech, Elias was a Research & Development New Product Development Engineer and Test Services Technician for Heartware, Apollo Endosurgery and Cordis Johnson & Johnson. Elias holds a BS in Engineering from Miami Dade Community College.
Taimy has over two decades of experience with many aspects of Human Resources, ranging from human capital management to strategic thinking/planning and change management. Her passion is providing HR solutions for clients through technology, retention, activities and people. Prior to joining Naglreiter, she worked for QatarGas as Head of Contracts and Administration. In this role she managed all related administrative, contractual, accounting and administration for an annual budget of over $20M. Before her role at QatarGas, she was the Accounting Manager for AECOM where she managed all financial activities for the firm with yearly gross revenue of $24M. Taimy holds a Bachelor of Science in Business and Professional Management from Nova Southeastern University.
NAGLREITER™ employs a diverse, experienced staff of Workforce Associates including:
- Program Managers
- Design Engineers
- Product Development Engineers
- Regulatory Specialists
- Solid Modeling / CADD Specialists
- Packaging Development Engineers
- Process Development Engineers
- Validation Engineers
- Micro-Biologists / Sterilization Specialists
- Machinists / Tool Development Specialists
- FEA Modeling / Shape Memory Alloy Specialists
- Quality Engineers
- Patent Agent / IP Management
- Clinical Specialist