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Principal R&D Engineer

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Job Description - Principal R&D Engineer

Act as an independent leader in a supportive team environment Effective design, development, and project engineering Engage physicians, patients, sales reps, marketing, and others to collect feedback for devices under development Deliver meaningful innovation and submit novel intellectual property Create specifications and perform engineering analyses Design for cost-effective manufacturability Develop and analyze project scopes and schedules Define and validate manufacturing processes, support engineering builds, and verify product performance. Train and mentor entry-level engineers Stay abreast of emerging technologies, trends, and competition. Deliver designs that meet goals such as performance, standards, manufacturability, reliability, and cost. Generate regulatory audit worthy design and risk management documentation Experience as a design originator/owner and project engineer in the medical device industry, responsible for new implantable and external device designs, materials, equipment, and processes. Education in Mechanical or Biomedical engineering with a B.S. and 7+ years of experience or M.S. and 5+ years of work experience commercializing product. Direct experience utilizing SolidWorks 3D CAD and drafting standards (e.g., ANSI Y14.5) Experience executing projects through commercial launch Experience involving/supporting most of the following: Implantable leads, implantable pulse generators, surgical tools, access instruments, or handheld and wearable devices Materials biocompatibility Animal studies, preclinical studies, cadaver lab, field research and clinical studies to evaluate the usability and performance of designed products
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