
Chuck Lennox
Medical Device - R&D – Product Development – Design Quality – Clinical/Regulatory Affairs • Extensive design quality, R&D, and... | Hudson, New Hampshire, United States
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Chuck Lennox’s Location Hudson, New Hampshire, United States
Chuck Lennox’s Expertise Medical Device - R&D – Product Development – Design Quality – Clinical/Regulatory Affairs • Extensive design quality, R&D, and product development experience including: user and design specification development; design controls; design verification and validation; HHA and FMEA; DHF/DMR maintenance and remediation; design standards conformance; and CAPA investigations. • Regulatory submissions including IDE, IRB, and 510(k). • Pre-clinical study management; clinical monitoring, and clinical site training. • In depth knowledge of disease states and treatment modalities in the fields of interventional cardiology, radiology, and neuroradiology, neurosurgery, urology, gynecology, gastroenterology, electro-physiology, and emergency medicine. • Technical expertise in lasers and fiber optics, electro-surgery, cryo-surgery, endoscopic instruments, catheter development, heat and light interaction with tissue, mechanical design, biomaterials, implants and electromechanical systems integration. • In depth knowledge of: 21 CFR 50, 21 CFR 58, 21 CFR 801, 21 CFR 812, 21 CFR 820, ISO 14971, ISO 13485, ISO 14630, & ISO 22442 • Successful track record in project planning, budgeting, program management and business development. • Masters of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University. 47 Issued US Medical Device Patents
Chuck Lennox’s Current Industry Enhanced Compliance
Chuck
Lennox’s Prior Industry
Boston Scientific
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Medcool
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Smiths Medical
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Mdi Consulting
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Work Experience

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Principle Engineering Consultant
Fri Apr 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Mdi Consulting
Upstream R&D and IP Development Consultant
Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Smiths Medical
R&D Manager
Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Medcool
Founder, Director and CTO
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Boston Scientific
Technology Manager, New Business Development
Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)
Boston Scientific
Manager, Corporate Research and Development
Thu Jan 01 1987 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)