Lucas Gamero
VP of Engineering
- Role
- VP of Engineering at VERO Biotech
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Lucas Gamero
Seasoned product development executive with over 20 years of experience in the medical device and pharmaceutical industries. Creative, innovative, goal-oriented, and results-driven engineering manager. Strong problem-solving skills and technical background with 12 peer-reviewed publications, over 50 presentations at technical conferences, one issued patent, and several patent applications in the US and Europe. Responsible for concept design, specifications, research, development, and design transfer of complex diagnostic and therapeutic devices and drug/device combination products (with associated disposables). Contributed to several regulatory submissions: 510ks, INDs, and NDAs for medical devices and combination products. Participated in FDA on-site audits as subject matter expert in design controls, software validation, and product verification and validation.Hands-on experience developing complex algorithms and signal/image processing for several medical devices: ECG, EEG, arterial pressure, heart rate variability, heart sounds/murmur detection, impedance cardiography, LASIK, physiological closed-loop control systems, and medical imaging.Proven track record of hiring and mentoring new technical staff. Experienced in the successful management of cross-functional teams, external partnerships, and distributed groups of engineers.Specialties: R&D technical management, program management, new product development, medical devices, combination products, software/hardware/embedded design, risk management, signal and image processing, control systems, algorithms, medical device regulatory affairs, clinical research, design controls, V&V and design transfer to manufacturing.
Experience
VP of Engineering
Jan 2012 — Present · Cocoa, FL, US
Education
Universidad Nacional de Entre Ríos
BS, Biomedical Engineering
1987 — 1994
University of Buenos Aires
PhD. in Engineering
1998 — 2002
Universidad Favaloro
MSc, Biomedical Engineering
1994 — 1997
Skills
- Matlab
- Medical Devices
- Engineering Management
- Verification & Validation
- Iso 13485
- Research and Development (R&D)
- Fda
- Quality System
- R&D
- Design Control
- Biomedical Engineering
- Product Development
- Embedded Systems
- Electronics
- Sensors
- Manufacturing
- Algorithm Development
- Signal Processing
- Design Controls
- Systems Engineering
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