David Wolf-Bloom
- Role
- Senior Manager, Clinical Development Engineering at Intuitive
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About David Wolf-Bloom
A results-oriented, hands-on medical device professional and leader with a proven record…
Experience
Senior Manager, Clinical Development Engineering
Aug 2019 — Present
Lead a team of managers and clinical development engineers (CDEs) supporting the development of our Multi-port (MP) and Single-port (SP) robotic platforms including software development and system integration and the development of our Digital & Data products - CDE activities include clinical needs finding, developing product requirements, clinical risk management, product testing and validation using various in vivo, ex vivo, and cadaveric models, and supporting clinical trials and commercial launch - Collaborate with cross functional teams including design engineering (SW, HW, SA), IxD, HF, Marketing, Quality, Regulatory, Clin Affairs, and PMO in the development of next generation systems
Skills
- Manufacturing Engineering
- Biomedical Engineering
- Commercialization
- Verification and Validation (V&V)
- Quality System
- Manufacturing
- Management
- Corrective and Preventive Action (Capa)
- Model Making
- Guidewires
- Catheters
- 3d Printing
- Medical Devices
- Research and Development (R&D)
- Biomaterials
- Injection Molding
- Cross-Functional Team Leadership
- Iso 25539-2
- V&V
- Product Development
- Gmp
- Design Control
- Fda
- Dfx
- U.s. Food and Drug Administration (Fda)
- Stents
- Iso 13485
- R&D
- Testing
- Drug Eluting Stents
- Validation
- Product Launch
- Design of Experiments
- Capa
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