Hybrid : Remote Sr. Mechanical Design Engineer : Robotics / Kinematics / MechanismsSr. Mechanical Design EngineerSurgical Navigation : Medical DeviceRobotic/Mechatronic MechanismsHybrid / Remote : Cleveland, OHOur client is developing a surgical navigation tool to enable and aid surgeons in the accurate placement of implants in orthopedic procedures. This proprietary 3D navigation system is designed to improve the accurate placement of implants and reduce complication rates.As the Senior Mechanical Design Engineer, you will be responsible for developing mechanical systems solutions for our next generation kinematic surgical navigation system.Responsibilities:Lead the design and development of advanced kinematic systems, focusing on manipulator design, kinematics (both forward and inverse), state estimation, and comprehensive system modeling.Apply a deep understanding of mechanism design, ensuring efficient packaging of electronic subsystems within the manipulator's mechanical structure.Ensure all designs are compliant with FDA guidelines, focusing on sterility standards and other design requirements specific to medical devices.Utilize CAD software, coupled with the associated PDM/PLM systems, to draft and refine designs in a revision-controlled manner.Conduct simulations and analyses, including kinematic, stress, thermal, and vibration, using both simulation tools and hand calculations.Engage in hands-on prototyping, debugging, and testing of electro-mechanical systems, iterating designs based on the results.Ensure designs are optimized for manufacturing, keeping in mind relevant manufacturing processes, GD&T, and other production considerations.Use basic programming skills in Python, MATLAB, and/or C/C++ to run tests, gather data, and analyze the performance of the electro-mechanical hardware systems.Manage all design control documentation as it relates to mechanical design.Evaluate potential failure modes of the designs and conduct Design Failure Mode and Effects Analysis (DFMEA) to identify and mitigate potential risks.Collaborate closely with multidisciplinary design teams, ensuring that electrical, mechanical, and software systems are integrated seamlessly.Maintain a high standard of excellence and professionalism, operating efficiently in a high-paced and impactful role.Communicate effectively, articulating design choices and challenges to stakeholders, and work well both as part of a team and autonomously.Understand and apply principles of thermal management and thermal isolation, especially in the context of sterile reprocessing and exposure of electronic devices to extreme temperatures.Participate in human factors analysis during the design phase, focusing on system setup, sterility, and developing clinical workflows that align with the electro-mechanical system's capabilities.Develop and manage comprehensive test plans related to validation/verification activities and quantify system performance, ensuring data is organized and prepared for FDA submission and evaluation.Qualifications and Education:BS and 8+ years of experience or MS and 6+ years of experience in mechanical, biomedical engineering, or equivalent (Class II or III medical device experience required).Experience with robotic systems and manipulator design, especially forward/inverse kinematics, state estimation, and system modeling.Deep understanding of mechanism design and packaging of electronic systems.Experience operating within a Quality Management System and managing required documentation as it relates to the mechanical design of a system.High proficiency with CAD software (Solidworks preferred).Experience with performing kinematic, stress, thermal, and vibration analysis using simulation tools and/or hand calculations.Hands-on prototyping, debugging, and testing experience.Experience with design for manufacturing, especially with consideration of relevant manufacturing processes and GD&T.Sound understanding of failure modes and conducting risk analyses to determine and mitigate potential risks.Experience working as a member of a multidisciplinary design team, where electrical, mechanical, and software systems must work together.Excellent communication skills and ability to thrive in a team as well as autonomously.Preferred Qualifications:Experience with thermal management and thermal isolation, especially as it relates to sterile reprocessing and extreme temperature exposure of sensitive electronic devices.Basic programming ability in Python, MATLAB, and/or C/C++ to test and analyze the performance of hardware systems.Understanding of human factors analysis as it relates to system setup, sterility, and clinical workflow development.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering and DesignIndustriesMedical Equipment Manufacturing
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