Core competency in the medical device Product Development Process (PDP), from early conceptualization through transfer to manufacturing. Design & Development; Innovation & Validation.

Rev.1 Engineering is a comprehensive Product Design, Development and Engineering Company specializing in Medical Technology. We provide expertise in every step of the product development process; from conception to creation, to include: Idea Generation, Patent Application, Design, Prototype Creation, Development, Testing, Verification, Validation and Product Manufacturing.SpecialtiesMedical Device Research, Design Proof of concept and development, IP creation, Mechanical Engineering, Business Planning, Product and Business Incubation, Project Planning and Manufacturing.

First engineer hired in a round A start-up neurovascular company.Fulfill a multi-functional role, including R&D, product development, manufacturing, purchasing, materials, quality, pre-clinical, and clinical in a start-up environment.Designed and developed a thermal-detachment delivery system for neurovascular implants. System comprised of mechanical components, an electrical circuit board and an injection molded housing. Provide clinical case support for limited commercial release in Europe.Interim manager of manufacturing and operations. Duties include supervising assemblers and temps, train operators, maintain materials inventory, perform lot audits, track yield data, manage build schedule, maintain quality documents. Grew department from 1 operator to 3 operators, 4 temps and one tech. Scheduled, staffed and supervised 2nd shift to meet aggressive timelines.Write Manufacturing Instructions, Manufacturing Routers, Product Drawings, Test Methods, Inspection Procedures, Equipment Specifications, engineering protocols and reports.

Lead engineer responsible for the design and development of Side Branch Access stent delivery systems. Responsible for concept, design, development, validation, and transfer to manufacturing. Supervise engineers, technicians and operators. Perform qualifications including protocol and report writing. Work directly with quality, manufacturing, regulatory, marketing, machine shop, extrusion, vendors. Manage R&D lab, technicians and temporary employees.Manage fluoroscopy and heart model labs.Design, develop and fabricate clinically relevant synthetic models for interventional device testing. Models are used worldwide for prototype R&D testing, sales force training, product demonstration, physician training, clinical trials, and marketing. Conduct acute GLP animal studies including study design, writing protocols and reports. Extensive experience with CAD, project management, supervision, and physician-customer interaction.