Mech Design Eng - P5

Works with physicians, sales, marketing, plus other functional areas to understand and document translated customer needs into requirements specifications. Acts as project engineer to manage the scope, schedule, and resources for assigned projects. Actively supports established department plus personal goals and objectives. Monitors project progress and regularly reports progress to manager. Owns or may contribute to marketing specifications, engineering specifications, feasibility plan/testing/reports, cost estimation/analysis, detailed mechanical engineering design, design reviews, risk analysis, hazard analysis, FMEA-Design/Process/Use, tolerance analysis, material analysis, force analysis, stress analysis, thermal analysis, dynamic analysis, molding analysis, manufacturing equipment definition/debug/validation, tooling definition/debug/validation, process definition/debug/validation, engineering builds, and product verification testing. Successfully garners necessary project support (internal resources such as manufacturing engineers and technicians; external resources such as test labs, software such as for analysis, equipment and test fixtures such as for pull testing, etc.). Works to seek approval for viable products or product enhancements that meet or exceed customer needs. Seeks discovery and development of new technologies or product lines. Recommends ideas for patent protection/coverage. Supports ongoing departmental activities such as scheduled meetings, budgeting, screening/interviewing prospective job candidates, etc Effective design, development, and project engineering Meet with and 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 Support creation of project scopes and schedules Define and validate designs, manufacturing processes, support engineering builds, and verify product performance. 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 Education in Mechanical or Biomedical engineering with a B.S. and 8+ years of experience or M.S. and 5+ years of work experience. Experience as a hands-on design and project engineer in the medical device industry, responsible for new implantable and external device designs, materials, equipment, and processes. Hands-on experience utilizing SolidWorks 3D CAD and drafting standards (e.g., ANSI Y14.5) Experience executing projects through commercial launch 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