Mike Boutillette
Director of Research and Development
- Role
- Senior Director of Research & Development at Gi Windows Surgical
- Location
- Sudbury, MA, US
- LinkedIn followers
- 500 followers
About Mike Boutillette
20 years experience as a medical device design and development professional. Past & current experience leading technical development of surgical tools and catheter based devices for imaging and therapeutic applications. Developed products for application in cardiovascular access and therapy, cardiac pacing, orthopedic surgery, upper & lower GI therapies, pulmonary endoscopy and women\'s / reproductive health, all for clinical and/or commercial release as applicable. Specialties- Project management / team management- Mechanical design of innovative devices to diagnose & treat disease- Design for manufacturing- Creating specifications based on anatomy / disease state / regulatory requirements- Implementing and utilizing design control procedures- Implementing and utilizing risk management procedures- Communication, working with and leading teams- Pre-clinical device evaluation and clinical readiness- Design verification and validation- Process validation- Statistical analysis, sampling techniques and process development (sampling, data analysis, DOE\'s, Gage R&R\'s, etc)- Proficient with Solidworks, MiniTab and other engineering software packages.
Experience
Senior Director of Research & Development
Apr 2022 — Present · MA, US
Education
Worcester Polytechnic Institute
Bachelor of Science (BS), Biomedical/Medical Engineering
1996 — 2000
Skills
- Fda
- Catheters
- Research and Development (R&D)
- Product Development
- Endoscopy
- Quality System
- V&V
- Process Simulation
- Cardiac
- Iso 13485
- Statistics
- Verification and Validation (V&V)
- Failure Mode and Effects Analysis (Fmea)
- Biomedical Engineering
- Process Capability
- Hazard Analysis
- Design for Manufacturing
- R&D
- Design Control
- Process Development
- Doe
- Validation
- Cross-Functional Team Leadership
- Biomaterials
- Iso 14971
- Product Design
- Testing
- Fmea
- Solidworks
- Clinical Development
- U.s. Food and Drug Administration (Fda)
- Gage R&Amp;R
- Design of Experiments
- Corrective and Preventive Action (Capa)
- Medical Devices
- Clinical Research
- Capa
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