Hybrid : Remote Sr. Mechanical Design Engineer : ...

Sr. Mechanical Design EngineerSurgical Navigation : Medical DeviceRobotic/Mechatronic MechanismsHybrid / Remote : Northern Ohio / 3 Hour RadiusManipulator design : Kinematics (Inverse/Forward)State Estimation : Dynamic System ModelingOur 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 complications rates. Our system converts free-hand procedures to guided procedures leading to improved implant placement, reduced complications, and reduced OR time.In orthopedic surgery, many procedures like hip fractures and ACL reconstructions are performed free-hand guided by 2D imaging that creates inconsistent implant placement which can lead to complications.As the Senior Mechanical Design Engineer, you will be responsible for developing mechanical systems solutions for our next generation kinematic surgical navigation system.This person wil lead the mechanical design and development of advanced kinematic systems, specifically focusing on manipulator design, kinematics (both forward and inverse), state estimation, and comprehensive system modeling.Responsibilities:o Lead the design and development of advanced kinematic systems, specifically focusing on manipulator design, kinematics (both forward and inverse), state estimation, and comprehensive system modeling.o Apply a deep understanding of mechanism design, ensuring efficient packaging of electronic subsystems within the manipulator's mechanical structure.o Ensure all designs are compliant with FDA guidelines, particularly focusing on sterility standards and other design requirements specific to medical devices. o Utilize CAD software, coupled with the associated PDM/PLM systems, to draftand refine designs in a revision controlled manner.o Conduct a range of simulations and analyses, including kinematic, stress,thermal, and vibration, using both simulation tools and hand calculations tovalidate designs.o Engage in hands-on prototyping, debugging, and testing of electro-mechanicalsystems, iterating designs based on the results.o Ensure designs are optimized for manufacturing, keeping in mind relevantmanufacturing processes, GD&T, and other production considerations.o Use basic programming skills in Python, MATLAB, and/or C/C++ to run tests,gather data, and analyze the performance of the electro-mechanical hardwaresystems.o Manage all design control documentation as it relates to mechanicalhardware design.o Evaluate potential failure modes of the designs and conduct Design FailureMode and Effects Analysis (DFMEA) to identify and mitigate potential risks.o Collaborate closely with multidisciplinary design teams, ensuring that electrical, mechanical, and software systems are integrated seamlessly to achieve desired outcomes.o Maintain a high standard of excellence and professionalism, operating efficiently in a high-paced and impactful role.o Communicate effectively, both in articulating design choices and challenges to stakeholders, and work well both as part of a team and autonomously.o Understand and apply principles of thermal management and thermalisolation, especially in the context of sterile reprocessing and exposure ofelectronic devices to extreme temperatures.o Participate in human factors analysis during the design phase, focusing onsystem setup, sterility, and developing clinical workflows that align with theelectro-mechanical system's capabilities.o Develop and manage comprehensive test plans related tovalidation/verification activities and quantify system performance, ensuring data is organized and prepared for FDA submission and evaluation.Qualifications and Education:o BS and 8+ years of experience or MS and 6+ years of experience inmechanical, biomedical engineering, or equivalent (Class II or III medicaldevice experience required)o Experience with robotic systems and manipulator design, especiallyforward/inverse kinematics, state estimation, and system modelingo Deep understanding of mechanism design and packaging of electronicsystemso Experience operating within a Quality Management System and managingrequired documentation as it relates to the mechanical design of a systemo High proficiency with CAD software (Solidworks preferred)o Experience with performing kinematic, stress, thermal, and vibration analysisusing simulation tools and/or hand calculationso Hands-on prototyping, debugging, and testing experienceo Experience with design for manufacturing, especially with consideration ofrelevant manufacturing processes and GD&To Sound understanding of failure modes and conducting various risk analysesto determine and mitigate potential riskso Experience working as a member of a multidisciplinary design team, whereelectrical, mechanical, and software systems must work together toaccomplish a desired outcomeo Excellent track record and the ability to work in a high pace, high impact role o Excellent communication skills and ability to thrive in a team as well asautonomously.Preferred Qualificationso Experience with thermal management and thermal isolation especially as itrelates to sterile reprocessing and extreme temperature exposure of sensitiveelectronic deviceso Basic programming ability in Python, MATLAB, and/or C/C++ to test andanalyze performance of hardware systemso Understanding of human factors analysis as it relates to system setup,sterility, and clinical workflow development

Created: 2024-10-19