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Start LLC specializes in full service medical device design consulting. We are experts in creative problem solving, intellectual property generation, prototype development, engineering design development, design for manufacture, engineering analysis, industrial design, ergonomic development, verification planning & testing and development planning & strategy. From program support through full device development partnering. ISO13485 certified.

•iDrive Ultra Reusable Powered Stapler System Adapters---Overcame serious design challenges and launched on schedule---Evaluated impact of detergents on reliability---Conducted root cause analysis---Conducted development testing---Improved prototype component sourcing and tracking---Improved development build tracking and traceability---Developed design input specifications---Developed system transfer functions•iDriveC Reusable Powered Stapler Systems---Managed transfer for external development of reusable battery---Conducted interface reliability for reusable battery---Successfully ensured battery never became critical path•Articulating laparoscopic hand instruments---Identified stalled external development and recommended internal transfer resulting in successful launch•Mentored and advised junior engineers

•Dry powder inhaler platform ---Managed $300k budget and schedule for inhaler development program---Developed scope, budget, schedule and resource plan for base platform development program for use in financial business plan---Conducted initial technical due diligence for potential device acquisition•Injectable drug delivery systems---Exenatide long acting release diabetes therapy collaboration with Eli Lilly and Amylin Pharmaceuticals ---Alliance device team leader, CMC and PWT team member---Early stage programs’ requirements definition and project plan development

Project manager, technical leader and inventor at the Ethicon Inc. flagship division of Johnson & Johnson. Conducted extensive field work with physicians and performed market research resulting in innovative product designs and business cases.•Acquisition technical transfer---R&D team member for $100MM acquisition•Intra-vascular catheter / port access devices---Conducted extensive field work with physicians and performed market research---Recommended manufacturing process development over new product development•Gynecare Prolift® Pelvic Floor Repair System mesh fixation device---Led development team through transfer to manufacture challenges to on schedule launch•Endoscopic vessel harvesting portable vision system---Led development team through design challenges to on schedule launch•NPD projects - Lead mechanical engineer and/or inventor:---Distal anastomosis device---Device for thermal RF ablation of nerves within a vertebral body---Minimally invasive RF electro-surgical organ transaction device---Minimally invasive RF tumor ablation device---Next generation GYNECARE THERMACHOICE minimally invasive therapy system---Percutaneous arterial closure devices•Chaired the product development Best Practices group.

Project manager, technical leader and inventor for leading medical single use disposables manufacturer.•Hypodermic Needle-Pro® EDGE™---Led exploratory / discovery teams including business plan development and field research resulting in successful new product line•Successfully launched 3 new NeedlePro® needle protection product lines as project manager, technical leader and inventor on time and on budget.---Small Gauge Hypodermic Needle-Pro® Device---Fixed Needle Syringes with Needle-Pro® Device---Hypodermic Needle-Pro® for Tubex® drug cartridges•Responsible for successful quality system audits of design history files.